Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Recall Initiated
- September 10, 2015
- Posted
- October 22, 2015
- Terminated
- June 23, 2021
- Recall Number
- Z-0158-2016
- Quantity
- 1246 units
- Firm Location
- Mansfield, MA
Reason for Recall
Sterility of device is compromised due to breach in the packaging
Distribution
Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela
Lot / Code Info
50069280 50214249 50260936 50334160 50380067 50410625 50442600 50084563 50217938 50266144 50337465 50383809 50412120 50448621 50097669 50227860 50276674 50352665 50385382 50415177 50451051 50112174 50231228 50282533 50353524 50389835 50416603 50451744 50117989 50236270 50310331 50356943 50391478 50424410 50452069 50131406 50242373 50317889 50362696 50396029 50428473 50455380 50139181 50246739 50320168 50370396 50399036 50428686 50457280 50148410 50254144 50324084 50372214 50401621 50432549 50461109 50199543 50254145 50328908 50374300 50404803 50436553 50469462 50203454 50258249 50332285 50378312 50407329 50436675 50475144 50481307
Root Cause
Package design/selection
Action Taken
Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & Nephew's Field Action Department via email at FieldActions@smithnephew. com or fax +1-901-566-7975 to obtain a return authorization (RA) number. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.