Recall Z-1043-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number: 183126
| Date | Jan 30, 2023 (initiated Dec 29, 2022) |
| Status | Open, Classified |
| Reason | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). |
| Root cause | Labeling Change Control |
| Action | UPDATE: 2/7/23 Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL EXPANSION Letter on 2/07/23 to Distributors, Risk Manager, Surgeons. (An Urgent Medical Device Letter issued to consignees new accounts not previously notified Dec 29, 2022). Letters state reason for recall, health risk and action to take: This is a 14-lot scope expansion to the recall notification initiated on December 29, 2022, for the Vanguard Posterior Stabilized Open Box Femoral components. Letter states reason for recall, health risk and action to take: . Immediately locate and quarantine affected product in your invento |
| Quantity | 91 units |
| Distribution | International distribution to the countries of: Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. Expanded Recall US states of: FL, IN, MD, OH, PA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113550 | VANGUARD COMPLETE KNEE SYSTEM Biomet Manufacturing Corp, Feb 29, 2012 |