A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
This recall has been terminated (originally issued July 27, 2017).
- Company
- Zimmer Surgical Inc
- Recall Initiated
- July 27, 2017
- Terminated
- August 1, 2019
- Recall Number
- Z-0613-2018
- Quantity
- 8,231 devices total
- Firm Location
- Dover, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
Distribution
Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..
Lot / Code Info
Lot No. Item No. 60400040400, Lot No. 62510548 (Serial Numbers: 2213JAAA, 2213JAAB, 2213JAAC, 2213JAAD, 2213JAAE, 2213JAAF, 2213JAAG, 2213JAAH, 2213JAAJ, 2213JAAK, 2213JAAL, 2213JAAM, 2213JAAN, 2213JAAP, 2213JAAQ, 2213JAAR, 2213JAAS, 2213JAAT, 2213JAAU, 2213JAAW, 2213JABA, 2213JABB, 2213JABC, 2213JABD, 2213JABE, 2213JABF, 2213JABG, 2213JABH); Lot No. 62534445 (Serial Numbers: 2213JABJ, 2213JABK, 2213JABL, 2213JABM, 2213JABN, 2213JABP, 2213JABQ, 2213JABR, 2213JABS, 2213JABT, 2213JABU, 2213JABW, 2213JACA, 2213JACB, 2213JACC, 2213JACD, 2213JACE, 2213JACF, 2213JACG, 2213JACH); Lot No. 62631977 (Serial Numbers: 2214BAAA, 2214BAAB, 2214BAAC, 2214BAAD, 2214BAAE, 2214BAAF, 2214BAAG, 2214BAAH, 2214BAAJ, 2214BAAK, 2214BAAL, 2214BAAM, 2214BAAN, 2214BAAP, 2214BAAQ, 2214BAAR, 2214BAAS, 2214BAAT, 2214BAAU, 2214BAAW); Lot No. 62625059 (Serial Numbers: 2214BABA, 2214BABB, 2214BABC, 2214BABD, 2214BABE, 2214BABF, 2214BABG, 2214BABH, 2214BABJ, 2214BABK, 2214BABL, 2214BABM, 2214BABN, 2214BABP, 2214BABQ, 2214BABR, 2214BABS, 2214BABT, 2214BABU, 2214BABW); Lot No. 62635789 (Serial Numbers: 2214CAAA, 2214CAAB, 2214CAAC, 2214CAAD, 2214CAAE, 2214CAAF, 2214CAAG, 2214CAAH, 2214CAAJ, 2214CAAK, 2214CAAL, 2214CAAM, 2214CAAV, 2214CAAP, 2214CAAQ, 2214CAAR, 2214CAAS, 2214CAAT, 2214CAAU, 2214CAAW); Lot No. 62642067 (Serial Numbers: 2214DAAA, 2214DAAB, 2214DAAC, 2214DAAD, 2214DAAE, 2214DAAF, 2214DAAG, 2214DAAH, 2214DAAJ, 2214DAAK, 2214DAAL, 2214DAAM, 2214DAAN, 2214DAAP, 2214DAAQ, 2214DAAR, 2214DAAS, 2214DAAT, 2214DAAU, 2214DAAW); Lot No. 62642068 (Serial Numbers: 2214EAAA, 2214EAAB, 2214EAAC, 2214EAAD, 2014EAAE, 2214EAAF, 2214EAAG, 2214EAAH, 2214EAAJ, 2214EAAK, 2214EAAL, 2214EAAM, 2214EAAN, 2214EAAP, 2214EAAQ, 2214EAAR, 2214EAAS, 2214EAAT, 2214EAAU, 2214EAAW); Lot No. 62675190 (Serial Numbers: 2214DABA); Lot No. 62732714 (Serial Numbers: 2214FAAA, 2214FAAB, 2214FAAC, 2214FAAD); Lot No. 62727347 (Serial Numbers: 2214FAAE, 2214FAAF, 2214FAAG, 2214FAAH); Lot No. 62727348 (Serial Numbers: 2214FAAJ, 2214FAAK, 2214FAAL); Lot No. 62745916 (Serial Numbers: 2214FAAM, 2214FAAN); Lot No. 62723747 (Serial Numbers: 2214FAAP, 2214FAAQ, 2214FAAR, 2214FAAS, 2214FAAT, 2214FAAU, 2214FAAW, 2214FABA, 2214FABB, 2214FABC, 2214FABD, 2214FABE, 2214FABF, 2214FABG, 2214FABH, 2214FABJ, 2214FABK, 2214FABL, 2214FABM, 2214FABN); Lot No. 62723748 (Serial Numbers: 2214FABP, 2214FABQ, 2214FABR, 2214FABS, 2214FABT, 2214FABU, 2214FABW, 2214FACA, 2214FACB, 2214FACC, 2214FACD, 2214FACE, 2214FACF, 2214FACG, 2214FACH, 2214FACJ, 2214FACK, 2214FACL, 2214FACM, 2214FACN); Lot No. 62758708 (Serial Numbers: 2214GAAA, 2214GAAB, 2214GAAC, 2214GAAD); Lot No. 62758711 (Serial Numbers: 2214GAAE); Lot No. 62760907 (Serial Numbers: 2214GAAF, 2214GAAG); Lot No. 63773338 (Serial Numbers: 2214GAAH, 2214GAAJ, 2214GAAK, 2214GAAL); Lot No. 62773820 (Serial Numbers: 2214GAAM, 2214GAAN); Lot No. 62773463 (Serial Numbers: 2214GAAP); Lot No. 62773471 (Serial Numbers: 2214GAAQ, 2214GAAR, 2214GAAS); Lot No. 62773478 (Serial Numbers: 2214GAAT, 2214GAAU, 2214GAAW, 2214GABA); Lot No. 62773485 (Serial Numbers: 2214GABB, 2214GABC); Lot No. 62748403 (Serial Numbers: 2214GABD, 2214GABE, 2214GABF, 2214GABG, 2214GABH, 2214GABJ, 2214GABK, 2214GABL, 2214GABM, 2214GABN, 2214GABP, 2214GABQ, 2214GABR, 2214GABS, 2214GABT, 2214GABU, 2214GABW, 2214GACA, 2214GACB, 2214GACC); Lot No. 62779664 (Serial Numbers: 2214GACD, 2214GACE); Lot No. 62797832 (Serial Numbers: 2214HAAA, 2214HAAB, 2214HAAC); Lot No. 62797833 (Serial Numbers: 2214HAAD, 2214HAAE, 2214HAAF, 2214HAAG, 2214HAAH); Lot No. 62799449 (Serial Numbers: 2214HAAJ, 2214HAAK, 2214HAAL, 2214HAAM, 2214HAAN, 2214HAAP, 2214HAAQ, 2214HAAR, 2214HAAS, 2214HAAT, 2214HAAU, 2214HAAW, 2214HABA, 2214HABB, 2214HABC, 2214HABD, 2214HABE, 2214HABF, 2214HABG, 2214HABH); Lot No. 62799475 (Serial Numbers: 2214HABJ, 2214HABK, 2214HABL, 2214HABM, 2214HABN, 2214HABP, 2214HABQ, 2214HABR, 2214HABS, 2214HABT, 2214HABU, 2214HABW, 2214HACA, 2214HACB, 2214HACC, 2214HACD, 2214HACE, 2214HACF, 2214HACG, 2214HACH); Lot No. 62824836 (Serial Numbers: 2214IAAA, 2214IAAB, 2214IAAC, 2214IAAD); Lot No. 62838042 (Serial Numbers: 2214IAAE, 2214IAAF, 2214IAAG, 2214IAAH); Lot No. 62812885 (Serial Numbers: 2214IAAJ, 2214IAAK, 2214IAAL, 2214IAAM, 2214IAAN, 2214IAAP, 2214IAAQ, 2214IAAR, 2214IAAS, 2214IAAT, 2214IAAU, 2214IAAW, 2214IABA, 2214IABB, 2214IABC, 2214IABD, 2214IABE, 2214IABF, 2214IABG, 2214IABH); Lot No. 62812853 (Serial Numbers: 2214IABJ, 2214IABK, 2214IABL, 2214IABM, 2214IABN, 2214IABP, 2214IABQ, 2214IABR, 2214IABS, 2214IABT, 2214IABU, 2214IABW, 2214IACA, 2214IACB, 2214IACC, 2214IACD, 2214IACE, 2214IACF, 2214IACG, 2214IACH); Lot No. 62846159 (Serial Numbers: 2214JAAA, 2214JAAB, 2214JAAC); Lot No. 62844916 (Serial Numbers: 2214JAAD); Lot No. 62869981 (Serial Numbers: 2214KAAE, 2214KAAF, 2214KAAG, 2214KAAH, 2214KAAJ); Lot No. 62871639 (Serial Numbers: 2214JAAE, 2214JAAF, 2214JAAG, 2214JAAH); Lot No. 62870928 (Serial Numbers: 2214KAAK, 2214KAAL, 2214KAAM, 2214KAAN, 2214KAAP, 2214KAAQ, 2214KAAR, 2214KAAS, 2214KAAT, 2214KAAU, 2214KAAW, 2214KABA, 2214KABB, 2214KABC, 2214KABD, 2214KABE, 2214KABF, 2214KABG, 2214KABH, 2214KABJ); Lot No. 62877932 (Serial Numbers: 221411110001, 221411110002, 221411110003, 221411110004, 221411110005, 221411110006, 221411110007, 221411110008, 221411110009, 221411110010); Lot No. 62885586 (Serial Numbers: 221411120001, 221411120002, 221411120003, 221411120004, 221411120005); Lot No. 62885587 (Serial Numbers: 221411120006, 221411120007, 221411120008, 221411120009, 221411120010, 221411120011, 221411120012, 221411120013, 221411120014, 221411120015); Lot No. 62895898 (Serial Numbers: 221411200001, 221411200002, 221411200003, 221411200004, 221411200005, 221411200006, 221411200007, 221411200008, 221411200009, 221411200010); Lot No. 62905257 (Serial Numbers: 221411240001); Lot No. 62904091 (Serial Numbers: 221411250001, 221411250002, 221411250003, 221411250004, 221411250005, 221411250006, 221411250007, 221411250008, 221411250009, 221411250010, 221411250011, 221411250012, 221411250013, 221411250014, 221411250015, 221411250016, 221411250017, 221411250018, 221411250019, 221411250020); Lot No. 62904093 (Serial Numbers: 221412010001, 221412010002, 221412010003, 221412010004, 221412010005, 221412010006, 221412010007, 221412010008, 221412010009, 221412010010, 221412010011, 221412010012, 221412010013, 221412010014, 221412010015, 221412010016, 221412010017, 221412010018, 221412010019, 221412010020); Lot No. 62879139 (Serial Numbers: 221412040001, 221412040002, 221412040003, 221412040004, 221412040005); Lot No. 62905838 (Serial Numbers: 221412080001, 221412080002, 221412080003, 221412080004, 221412080005); Lot No. 62895896 (Serial Numbers: 221412120001, 221412120002, 221412120003, 221412120004, 221412120005); Lot No. 62904123 (Serial Numbers: 221412150001, 221412150002, 221412150003, 221412150004, 221412150005, 221412150006, 221412150007, 221412150008, 221412150009, 221412150010, 221412150011, 221412150012, 221412150013, 221412150014, 221412150015, 221412150016, 221412150017, 221412150018, 221412150019, 221412150020); Lot No. 62932244 (Serial Numbers: 221412180001, 221412180002, 221412180003, 221412180004, 221412180005, 221412180006, 221412180007, 221412180008, 221412180009, 221412180010, 221412180011, 221412180012, 221412180013, 221412180014, 221412180015, 221412180016, 221412180017, 221412180018, 221412180019, 221412180020); Lot No. 62935217 (Serial Numbers: 221412190001, 221412190002, 221412190003, 221412190004, 221412190005); Lot No. 62937693 (Serial Numbers: 221501050001, 221501050002, 221501050003, 221501050004, 221501050005); Lot No. 62945082 (Serial Numbers: 221501080001, 221501080002, 221501080003, 221501080004, 221501080005); Lot No. 62945086 (Serial Numbers: 201501080006, 201501080007, 201501080008); Lot No. 62932650 (Serial Numbers: 221503090001, 221503090002, 221503090003, 221503090004, 221503090005, 221503090006, 221503090007, 221503090008, 221503090009, 221503090010, 221503090011, 221503090012, 221503090013, 221503090014, 221503090015, 221503090016, 221503090017, 221503090018, 221503090019, 22150309002); Lot No. 62961804 (Serial Numbers: 221503120001, 221503120002, 221503120003, 221503120004, 221503120005, 221503120006, 221503120007, 221503120008, 221503120009, 221503120010, 221503120011, 221503120012, 221503120013, 221503120014, 221503120015, 221503120016, 221503120017, 221503120018, 221503120019, 221503120020); Lot No. 62976480 (Serial Numbers: 221503190001, 221503190002, 221503190003, 221503190004, 221503190005, 221503190006, 221503190007, 221503190008, 221503190009, 221503190010, 221503190011, 221503190012, 221503190013, 221503190014, 221503190015, 221503190016, 221503190017, 221503190018, 221503190019, 221503190020); Lot No. 62976481 (Serial Numbers: 221503250001, 221503250002, 221503250003, 221503250004, 221503250005, 221503250006, 221503250007, 221503250008, 221503250009, 221503250010, 221503250011, 221503250012, 221503250013, 221503250014, 221503250015, 221503250016, 221503250017, 221503250018, 221503250019, 221503250020); Lot No. 63026460 (Serial Numbers: 221503270001, 221503270002, 221503270003, 221503270004, 221503270005); Lot No. 63007852 (Serial Numbers: 221504080001, 221504080002, 221504080003, 221504080004, 221504080005, 221504080006, 221504080007, 221504080008, 221504080009, 221504080010, 221504080011, 221504080012, 221504080013, 221504080014, 221504080015, 221504080016, 221504080017, 221504080018, 221504080019, 221504080020 Lot No. 63042181 (Serial Numbers: 221504140001, 221504140002, 221504140003, 221504140004, 221504140005); Lot No. 63042182 (Serial Numbers: 221504140006, 221504140007, 221504140008, 221504140009, 221504140010); Lot No. 63007853 (Serial Numbers: 221504140011, 221504140012, 221504140013, 221504140014, 221504140015, 221504140016, 221504140017, 221504140018, 221504140019, 221504140020, 221504140021, 221504140022, 221504140023, 221504140024, 221504140025, 221504140026, 221504140027, 221504140028, 221504140029, 221504140030); Lot No. 63042179 (Serial Numbers: 221504160001, 221504160002, 221504160003); Lot No. 63042184 (Serial Numbers: 221504220001, 221504220002, 221504220003, 221504220004, 221504220005); Lot No. 63037252 (Serial Numbers: 221504250001, 221504250002, 221504250003, 221504250004, 221504250005, 221504250006, 221504250007, 221504250008, 221504250009, 221504250010, 221504250011, 221504250012, 221504250013, 221504250014, 221504250015, 221504250016, 221504250017, 221504250018, 221504250019, 221504250020); Lot No. 63042180 (Serial Numbers: 221504280001, 221504280002, 221504280003, 221504280004, 221504280005, 221504280006, 221504280007, 221504280008, 221504280009, 221504280010, 221504280011, 221504280012, 221504280013, 221504280014, 221504280015, 221504280016, 221504280017, 221504280018, 221504280019, 221504280020); Lot No. 63042183 (Serial Numbers: 221505110001, 221505110002, 221505110003, 221505110004, 221505110005); Lot No. 63037254 (Serial Numbers: 221505120001, 221505120002, 221505120003, 221505120004, 221505120005, 221505120006, 221505120007, 221505120008, 221505120009, 221505120010, 221505120011, 221505120012, 221505120013, 221505120014, 221505120015, 221505120016, 221505120017, 221505120018, 221505120019, 221505120020); Lot No. 63092209 (Serial Numbers: 221506030001, 221506030002, 221506030003); Lot No. 63092210 (Serial Numbers: 221506050001, 221506050002, 221506050003, 221506050004, 221506050005); Lot No. 63072301 (Serial Numbers: 221506100001, 221506100002, 221506100003, 221506100004, 221506100005, 221506100006, 221506100007, 221506100008, 221506100009, 221506100010, 221506100011, 221506100012, 221506100013, 221506100014, 221506100015, 221506100016, 221506100017, 221506100018, 221506100019, 221506100020); Lot No. 63103587 (Serial Numbers: 221506130001, 221506130002, 221506130003, 221506130004, 221506130005, 221506130006, 221506130007, 221506130008, 221506130009, 221506130010, 221506130011, 221506130012, 221506130013, 221506130014, 221506130015); Lot No. 63072324 (Serial Numbers: 221506170001, 221506170002, 221506170003, 221506170004, 221506170005, 221506170006, 221506170007, 221506170008, 221506170009, 221506170010, 221506170011, 221506170012, 221506170013, 221506170014, 221506170015, 221506170016, 221506170017, 221506170018, 221506170019, 221506170020); Lot No. 63103164 (Serial Numbers: 221506170021, 221506170022, 221506170023); Lot No. 63072352 (Serial Numbers: 221506200001, 221506200002, 221506200003, 221506200004, 221506200005, 221506200006, 221506200007, 221506200008, 221506200009, 221506200010, 221506200011, 221506200012, 221506200013, 221506200014, 221506200015, 221506200016, 221506200017, 221506200018, 221506200019, 221506200020); Lot No. 63096468 (Serial Numbers: 221507150001, 221507150002, 221507150003, 221507150004, 221507150005, 221507150006, 221507150007, 221507150008, 221507150009, 221507150010, 221507150011, 221507150012, 221507150013, 221507150014, 221507150015, 221507150016, 221507150017, 221507150018, 221507150019, 221507150020); Lot No. 63109655 (Serial Numbers: 221507160001, 221507160002, 221507160003); Lot No. 63103590 (Serial Numbers: 221507210001, 221507210002, 221507210003, 221507210004, 221507210005, 221507210006, 221507210007, 221507210008, 221507210009, 221507210010, 221507210011, 221507210012, 221507210013, 221507210014, 221507210015); Lot No. 63109651 (Serial Numbers: 221507280001, 221507280002, 221507280003, 221507280004, 221507280005, 221507280006, 221507280007, 221507280008, 221507280009, 221507280010); Lot No. 63116357 (Serial Numbers: 221507290001, 221507290002, 221507290003, 221507290004, 221507290005, 221507290006, 221507290007, 221507290008, 221507290009, 221507290010, 221507290011, 221507290012, 221507290013, 221507290014, 221507290015, 221507290016, 221507290017, 221507290018, 221507290019, 221507290020); Lot No. 63123305 (Serial Numbers: 221508040001, 221508040002, 221508040003, 221508040004, 221508040005, 221508040006, 221508040007, 221508040008, 221508040009, 221508040010, 221508040011, 221508040012, 221508040013, 221508040014, 221508040015, 221508040016, 221508040017, 221508040018, 221508040019, 221508040020); Lot No. 63138553 (Serial Numbers: 221508260001, 221508260002, 221508260003, 221508260004, 221508260005, 221508260006, 221508260007, 221508260008, 221508260009, 221508260010, 221508260011, 221508260012, 221508260013, 221508260014, 221508260015, 221508260016, 221508260017, 221508260018, 221508260019, 221508260020); Lot No. 63138631 (Serial Numbers: 221509090001, 221509090002, 221509090003, 221509090004, 221509090005, 221509090006, 221509090007, 221509090008, 221509090009, 221509090010, 221509090011, 221509090012, 221509090013, 221509090014, 221509090015, 221509090016, 221509090017, 221509090018, 221509090019, 221509090020); Lot No. 63171089 (Serial Numbers: 221509240001, 221509240002, 221509240003, 221509240004, 221509240005, 221509240006, 221509240007, 221509240008, 221509240009, 221509240010, 221509240011, 221509240012, 221509240013, 221509240014, 221509240015, 221509240016, 221509240017, 221509240018, 221509240019, 221509240020); Lot No. 63202480 (Serial Numbers: 221510120001, 221510120002, 221510120003, 221510120004, 221510120005); Lot No. 63202478 (Serial Numbers: 221510220001, 221510220002, 221510220003, 221510220004, 221510220005, 221510220006, 221510220007, 221510220008, 221510220009, 221510220010, 221510220011, 221510220012, 221510220013, 221510220014, 221510220015, 221510220016, 221510220017, 221510220018, 221510220019, 221510220020); Lot No. 63234563 (Serial Numbers: 221511230001, 221511230002, 221511230003, 221511230004, 221511230005); Lot No. 63234565 (Serial Numbers: 221512020001, 221512020002, 221512020003, 221512020004, 221512020005); Lot No. 63212407 (Serial Numbers: 221512070001, 221512070002, 221512070003, 221512070004, 221512070005, 221512070006, 221512070007, 221512070008, 221512070009, 221512070010, 221512070011, 221512070012, 221512070013, 221512070014, 221512070015, 221512070016, 221512070017, 221512070018, 221512070019, 221512070020); Lot No. 63245752 (Serial Numbers: 221512160001, 221512160002, 221512160003, 221512160004, 221512160005, 221512160006, 221512160007); Lot No. 63253256 (Serial Numbers: 221512180001, 221512180002, 221512180003, 221512180004, 221512180005); Lot No. 63247425 (Serial Numbers: 221601060001, 221601060002, 221601060003, 221601060004, 221601060005, 221601060006, 221601060007, 221601060008, 221601060009, 221601060010, 221601060011, 221601060012, 221601060013, 221601060014, 221601060015, 221601060016, 221601060017, 221601060018, 221601060019, 221601060020); Lot No. 63526287 (Serial Numbers: 221612140001, 221612140002, 221612140003, 221612140004, 221612140005, 221612140006, 221612140007, 221612140008, 221612140009, 221612140010, 221612140011, 221612140012, 221612140013, 221612140014, 221612140015, 221612140016, 221612140017, 221612140018, 221612140019, 221612140020); Lot No. 63531691 (Serial Numbers: 221612150001, 221612150002, 221612150003, 221612150004, 221612150005, 221612150006, 221612150007); Lot No. 63526321 (Serial Numbers: 221612170001, 221612170002, 221612170003, 221612170004, 221612170005, 221612170006, 221612170007, 221612170008, 221612170009, 221612170010, 221612170011, 221612170012, 221612170013, 221612170014, 221612170015, 221612170016, 221612170017, 221612170018, 221612170019, 221612170020); Lot No. 63261584 (Serial Numbers: 221601070001, 221601070002, 221601070003, 221601070004, 221601070005); Lot No. 63264374 (Serial Numbers: 221601110001, 221601110002, 221601110003, 221601110004, 221601110005, 221601110006, 221601110007, 221601110008, 221601110009, 221601110010, 221601110011, 221601110012, 221601110013, 221601110014, 221601110015, 221601110016, 221601110017, 221601110018, 221601110019, 221601110020); Lot No. 63265280 (Serial Numbers: 221601140001, 221601140002, 221601140003, 221601140004, 221601140005, 221601140006, 221601140007); Lot No. 63257987 (Serial Numbers: 221601180001, 221601180002, 221601180003, 221601180004, 221601180005, 221601180006, 221601180007, 221601180008, 221601180009, 221601180010, 221601180011, 221601180012, 221601180013, 221601180014, 221601180015, 221601180016, 221601180017, 221601180018, 221601180019, 221601180020); Lot No. 63271202 (Serial Numbers: 221601220001, 221601220002, 221601220003, 221601220004, 221601220005); Lot No. 63258039 (Serial Numbers: 221602060001, 221602060002, 221602060003, 221602060004, 221602060005, 221602060006, 221602060007, 221602060008, 221602060009, 221602060010, 221602060011, 221602060012, 221602060013, 221602060014, 221602060015, 221602060016, 221602060017, 221602060018, 221602060019, 221602060020); Lot No. 63278388 (Serial Numbers: 221602150001, 221602150002, 221602150003, 221602150004, 221602150005, 221602150006, 221602150007, 221602150008, 221602150009, 221602150010, 221602150011, 221602150012, 221602150013, 221602150014, 221602150015, 221602150016, 221602150017, 221602150018, 221602150019, 221602150020); Lot No. 63278436 (Serial Numbers: 221602240001, 221602240002, 221602240003, 221602240004, 221602240005, 221602240006, 221602240007, 221602240008, 221602240009, 221602240010, 221602240011, 221602240012, 221602240013, 221602240014, 221602240015, 221602240016, 221602240017, 221602240018, 221602240019, 221602240020); Lot No. 63314121 (Serial Numbers: 221603090001, 221603090002, 221603090003); Lot No. 63314118 (Serial Numbers: 221603110001, 221603110002, 221603110003); Lot No. 63324625 (Serial Numbers: 221603220001, 221603220002, 221603220003); Lot No. 63336959 (Serial Numbers: 221603300001, 221603300002, 221603300003, 221603300004, 221603300005, 221603300006, 221603300007, 221603300008, 221603300009, 221603300010); Lot No. 63314042 (Serial Numbers: 221603300011, 221603300012, 221603300013, 221603300014, 221603300015, 221603300016, 221603300017, 221603300018, 221603300019, 221603300020, 221603300021, 221603300022, 221603300023, 221603300024, 221603300025, 221603300026, 221603300027, 221603300028, 221603300029, 221603300030); Lot No. 63341344 (Serial Numbers: 221604040001, 221604040002, 221604040003, 221604040004, 221604040005); Lot No. 63341346 (Serial Numbers: 221604050001, 221604050002, 221604050003, 221604050004, 221604050005, 221604050006, 221604050007, 221604050008, 221604050009, 221604050010); Lot No. 63314117 (Serial Numbers: 221604220001, 221604220002, 221604220003, 221604220004, 221604220005, 221604220006, 221604220007, 221604220008, 221604220009, 221604220010, 221604220011, 221604220012, 221604220013, 221604220014, 221604220015, 221604220016, 221604220017, 221604220018, 221604220019, 221604220020); Lot No. 63352349 (Serial Numbers: 221604250001, 221604250002, 221604250003); Lot No. 63339440 (Serial Numbers: 221605020001, 221605020002, 221605020003, 221605020004, 221605020005, 221605020006, 221605020007, 221605020008, 221605020009, 221605020010, 221605020011, 221605020012, 221605020013, 221605020014, 221605020015, 221605020016, 221605020017, 221605020018, 221605020019, 221605020020); Lot No. 63343366 (Serial Numbers: 221605060001, 221605060002, 221605060003, 221605060004, 221605060005, 221605060006, 221605060007, 221605060008, 221605060009, 221605060010, 221605060011, 221605060012, 221605060013, 221605060014, 221605060015, 221605060016, 221605060017, 221605060018, 221605060019, 221605060020, 221605060021, 221605060022); Lot No. 63352347 (Serial Numbers: 221605110001, 221605110002, 221605110003, 221605110004, 221605110005); Lot No. 63339497 (Serial Numbers: 221605120001, 221605120002, 221605120003, 221605120004, 221605120005, 221605120006, 221605120007, 221605120008, 221605120009, 221605120010, 221605120011, 221605120012, 221605120013, 221605120014, 221605120015, 221605120016, 221605120017, 221605120018, 221605120019, 221605120020); Lot No. 63378855 (Serial Numbers: 221606020001, 221606020002, 221606020003); Lot No. 63369605 (Serial Numbers: 221606110001, 221606110002, 221606110003, 221606110004, 221606110005, 221606110006, 221606110007, 221606110008, 221606110009, 221606110010, 221606110011, 221606110012, 221606110013, 221606110014, 221606110015, 221606110016, 221606110017, 221606110018, 221606110019, 221606110020); Lot No. 63403010 (Serial Numbers: 221606110021, 221606110022, 221606110023); Lot No. 63403012 (Serial Numbers: 221606150001, 221606150002, 221606150003, 221606150004, 221606150005, 221606150006, 221606150007, 221606150008); Lot No. 63403026 (Serial Numbers: 221606210001, 221606210002, 221606210003, 221606210004, 221606210005, 221606210006, 221606210007, 221606210008, 221606210009, 221606210010, 221606210011, 221606210012, 221606210013, 221606210014, 221606210015, 221606210016, 221606210017, 221606210018, 221606210019, 221606210020); Lot No. 63403009 (Serial Numbers: 221606220001, 221606220002, 221606220003); Lot No. 63403024 (Serial Numbers: 221606230001, 221606230002, 221606230003, 221606230004, 221606230005, 221606230006, 221606230007, 221606230008, 221606230009, 221606230010, 221606230011, 221606230012, 221606230013, 221606230014, 221606230015, 221606230016, 221606230017, 221606230018, 221606230019, 221606230020); Lot No. 63403025 (Serial Numbers: 221606240001, 221606240002, 221606240003, 221606240004, 221606240005, 221606240006, 221606240007, 221606240008, 221606240009, 221606240010); Lot No. 63403017 (Serial Numbers: 221606240011, 221606240012, 221606240013, 221606240014, 221606240015); Lot No. 63394148 (Serial Numbers: 221606290001, 221606290002, 221606290003, 221606290004, 221606290005, 221606290006, 221606290007, 221606290008, 221606290009, 221606290010, 221606290011, 221606290012, 221606290013, 221606290014, 221606290015, 221606290016, 221606290017, 221606290018, 221606290019, 221606290020); Lot No. 63410582 (Serial Numbers: 221607050001, 221607050002, 221607050003, 221607050004, 221607050005, 221607050006, 221607050007, 221607050008, 221607050009, 221607050010, 221607050011, 221607050012, 221607050013, 221607050014, 221607050015); Lot No. 63422767 (Serial Numbers: 221607080001, 221607080002, 221607080003, 221607080004, 221607080005, 221607080006, 221607080007, 221607080008, 221607080009, 221607080010, 221607080011, 221607080012, 221607080013, 221607080014, 221607080015, 221607080016, 221607080017, 221607080018, 221607080019, 221607080020); Lot No. 63410583 (Serial Numbers: 221607210001, 221607210002, 221607210003, 221607210004, 221607210005, 221607210006, 221607210007, 221607210008, 221607210009, 221607210010); Lot No. 63410585 (Serial Numbers: 221607220001, 221607220002, 221607220003, 221607220004, 221607220005, 221607220006, 221607220007, 221607220008, 221607220009, 221607220010); Lot No. 63394176 (Serial Numbers: 221607260001, 221607260002, 221607260003, 221607260004, 221607260005, 221607260006, 221607260007, 221607260008, 221607260009, 221607260010, 221607260011, 221607260012, 221607260013, 221607260014, 221607260015, 221607260016, 221607260017, 221607260018, 221607260019, 221607260020); Lot No. 63430499 (Serial Numbers: 221608080001, 221608080002, 221608080003, 221608080004, 221608080005, 221608080006, 221608080007, 221608080008, 221608080009, 221608080010, 221608080011, 221608080012, 221608080013, 221608080014, 221608080015, 221608080016, 221608080017, 221608080018, 221608080019, 221608080020); Lot No. 63437710 (Serial Numbers: 221608120001, 221608120002, 221608120003, 221608120004, 221608120005); Lot No. 63436338 (Serial Numbers: 221608160001, 221608160002, 221608160003, 221608160004, 221608160005); Lot No. 63445193 (Serial Numbers: 221608170001, 221608170002, 221608170003, 221608170004, 221608170005, 221608170006, 221608170007, 221608170008, 221608170009, 221608170010, 221608170011, 221608170012, 221608170013, 221608170014, 221608170015, 221608170016, 221608170017, 221608170018, 221608170019, 221608170020); Lot No. 63430540 (Serial Numbers: 221608190001, 221608190002, 221608190003, 221608190004, 221608190005, 221608190006, 221608190007, 221608190008, 221608190009, 221608190010, 221608190011, 221608190012, 221608190013, 221608190014, 221608190015, 221608190016, 221608190017, 221608190018, 221608190019, 221608190020); Lot No. 63445194 (Serial Numbers: 221608230001, 221608230002, 221608230003, 221608230004, 221608230005, 221608230006, 221608230007, 221608230008, 221608230009, 221608230010, 221608230011, 221608230012, 221608230013, 221608230014, 221608230015, 221608230016, 221608230017, 221608230018, 221608230019, 221608230020); Lot No. 63455066 (Serial Numbers: 221609010001, 221609010002, 221609010003, 221609010004, 221609010005, 221609010006, 221609010007, 221609010008, 221609010009, 221609010010, 221609010011, 221609010012, 221609010013, 221609010014, 221609010015, 221609010016, 221609010017, 221609010018, 221609010019, 221609010020); Lot No. 63474281 (Serial Numbers: 221609080001, 221609080002, 221609080003, 221609080004, 221609080005, 221609080006, 221609080007, 221609080008, 221609080009, 221609080010, 221609080011, 221609080012, 221609080013, 221609080014, 221609080015, 221609080016, 221609080017, 221609080018, 221609080019, 221609080020); Lot No. 63474283 (Serial Numbers: 221609080021, 221609080022, 221609080023, 221609080024, 221609080025, 221609080026); Lot No. 63474284 (Serial Numbers: 221609150001, 221609150002, 221609150003, 221609150004, 221609150005, 221609150006, 221609150007, 221609150008); Lot No. 63474287 (Serial Numbers: 221609210001, 221609210002, 221609210003, 221609210004, 221609210005, 221609210006, 221609210007, 221609210008, 221609210009, 221609210010); Lot No. 63474285 (Serial Numbers: 221610010001, 221610010002, 221610010003, 221610010004, 221610010005, 221610010006, 221610010007, 221610010008, 221610010009, 221610010010, 221610010011, 221610010012, 221610010013, 221610010014, 221610010015); Lot No. 63455098 (Serial Numbers: 221610050001, 221610050002, 221610050003, 221610050004, 221610050005, 221610050006, 221610050007, 221610050008, 221610050009, 221610050010, 221610050011, 221610050012, 221610050013, 221610050014, 221610050015, 221610050016, 221610050017, 221610050018, 221610050019, 221610050020); Lot No. 63474282 (Serial Numbers: 221610110001, 221610110002, 221610110003, 221610110004, 221610110005, 221610110006, 221610110007, 221610110008, 221610110009, 221610110010, 221610110011, 221610110012, 221610110013, 221610110014, 221610110015, 221610110016, 221610110017, 221610110018, 221610110019, 221610110020); Lot No. 63484747 (Serial Numbers: 221610140001, 221610140002, 221610140003, 221610140004, 221610140005); Lot No. 63482404 (Serial Numbers: 221610180001, 221610180002, 221610180003, 221610180004, 221610180005, 221610180006, 221610180007, 221610180008, 221610180009, 221610180010, 221610180011, 221610180012, 221610180013, 221610180014, 221610180015, 221610180016, 221610180017, 221610180018, 221610180019, 221610180020); Lot No. 63482405 (Serial Numbers: 221610200001, 221610200002, 221610200003, 221610200004, 221610200005, 221610200006, 221610200007, 221610200008, 221610200009, 221610200010, 221610200011, 221610200012, 221610200013, 221610200014, 221610200015, 221610200016, 221610200017, 221610200018, 221610200019, 221610200020); Lot No. 63482408 (Serial Numbers: 221611210001, 221611210002, 221611210003, 221611210004, 221611210005, 221611210006, 221611210007, 221611210008, 221611210009, 221611210010, 221611210011,221611210012, 221611210013, 221611210014, 221611210015, 221611210016, 221611210017, 221611210018, 221611210019, 221611210020); Lot No. 63501470 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501471 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501459 (Serial Numbers: 221611280001, 221611280002, 221611280003, 221611280004, 221611280005, 221611280006, 221611280007, 221611280008, 221611280009, 221611280010, 221611280011, 221611280012, 221611280013, 221611280014, 221611280015, 221611280016, 221611280017, 221611280018, 221611280019, 221611280020); Lot No. 63501486 (Serial Numbers: 221612020001, 221612020002, 221612020003, 221612020004, 221612020005, 221612020006, 221612020007, 221612020008, 221612020009, 221612020010, 221612020011, 221612020012, 221612020013, 221612020014, 221612020015, 221612020016, 221612020017, 221612020018, 221612020019, 221612020020); Lot No. 63501469 (Serial Numbers: 221612030001, 221612030002, 221612030003, 221612030004, 221612030005, 221612030006, 221612030007, 221612030008, 221612030009, 221612030010, 221612030011, 221612030012, 221612030013, 221612030014, 221612030015, 221612030016, 221612030017, 221612030018); Lot No. 63531693 (Serial Numbers: 221612050001, 221612050002, 221612050003, 221612050004, 221612050005); Lot No. 63501509 (Serial Numbers: 221612070001, 221612070002, 221612070003, 221612070004, 221612070005, 221612070006, 221612070007, 221612070008, 221612070009, 221612070010, 221612070011, 221612070012, 221612070013, 221612070014, 221612070015, 221612070016, 221612070017, 221612070018, 221612070019, 221612070020); Lot No. 63501547 (Serial Numbers: 221612100001, 221612100002, 221612100003, 221612100004, 221612100005, 221612100006, 221612100007, 221612100008, 221612100009, 221612100010, 221612100011, 221612100012, 221612100013, 221612100014, 221612100015, 221612100016, 221612100017, 221612100018, 221612100019, 221612100020); Lot No. 63501493 (Serial Numbers: 221612130001, 221612130002, 221612130003, 221612130004, 221612130005, 221612130006, 221612130007, 221612130008)
Root Cause
Use error
Action Taken
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE CORRECTIONS" letter dated 7/27/2017 to its customers via email or mail. The letter describes the product, problem and actions to be taken. Instructions for distributors include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, review the hospital list of customers that accompanied the notice and return contact information for any additional hospitals product was distributed to. Instructions for Risk Managers at hospitals include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, and complete and return the Attachment 1 form via email to corporatequality.postmarket@zimmerbiomet.com or ZimmerBiomet8287@stericycle.com or fax to 866-338-2611. If after reviewing this notification you have further questions or concerns please call +1(330) 364-0989 between 8:00 am and 5:00 pm EST, Monday through Friday.Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency.