Recall Z-0937-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
| Date | Dec 21, 2018 |
| Status | Terminated |
| Reason | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet conduct this recall to distributors and hospital risk managers that have unconsumed consigned inventory or inventory within their territory. Distributors notified via email on 12/21/18. Hospital risk managers, as well as distributors with product, will be notified via courier. Distributors issued letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand. Distributors to return on-hand product to Zimmer Biomet and ensure all of |
| Quantity | 45 units |
| Distribution | MN, VA Foreign: Korea, New Zealand and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040770 | VANGUARD PATELLA COMPONENTS Biomet Manufacturing, Inc., Apr 22, 2004 |