REF 70-0072-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, HOOK, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.
This recall has been terminated (originally issued August 24, 2010).
- Recall Initiated
- January 28, 2010
- Posted
- August 24, 2010
- Terminated
- December 15, 2010
- Recall Number
- Z-2256-2010
- Quantity
- 35,451 total
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
This recall was due to the possibility that multiple products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.
Distribution
Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.
Lot / Code Info
Lot Number: 76248, 76214, 76240, 76238, 76213, 76245, 76242, 76212, 76215, 92226, 92482, 92227, 92484, 92228, 92230, 92229, 92481, 95911, 92483, 109566, 109567, 109565, 110922, 115813, 115812, 115811, 116992, 116993, 116995, 116997, 116999, 117001, 116996, 116994, 117002, 117000, 116998, 117006, 117007, 117004, 117005, 119495, 119496, 120898, 119494, and 124206.
Root Cause
Material/Component Contamination
Action Taken
Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.