Device recall
Z-1607-2024: Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1607-2024 |
|---|---|
| Recall event | 94310 |
| Product | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid… |
| Product code | MBH |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K050222 |
| 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