Device recall
Z-1042-2023: (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1042-2023 |
|---|---|
| Recall event | 91489 |
| Product | (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard… |
| Product code | JWH |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K113550 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database