Recall Z-0590-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Manufacturing B.V.
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
| Date | Jan 5, 2016 (initiated Dec 3, 2015) |
| Status | Terminated |
| Reason | A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3. |
| Root cause | Labeling mix-ups |
| Action | Zimmer Biomet sent an "Urgent Medical Device Recall-Lot Specific" letter to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: Review the notification and ensure affected personnel are aware of the contents. 2. Locate all affected product identified above and quarantine them immediately. 3. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1). Email a completed copy of Attachment 1 to corporatequ |
| Quantity | 384 distribution events; 1 unit was returned leaving 383 units . |
| Distribution | Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933785 | NEXT GENERATION KNEE SYSTEM Zimmer, Inc., Jan 30, 1995 |