Device recall
Z-2148-2020: Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-2148-2020 |
|---|---|
| Recall event | 85524 |
| Product | Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Knee… |
| Product code | HRY |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2021 |
| 510(k) numbers | K133940 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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