Recall Z-1861-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint recon
| Date | Mar 27, 2017 (initiated Feb 17, 2017) |
| Status | Terminated |
| Reason | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
| Root cause | Process design |
| Action | On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. C |
| Quantity | 28,253 in total |
| Distribution | Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (S |
| FDA record | Open on fda.gov |