Device recall
Z-1224-2018: PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for…
FDA device recall · Class II · Zimmer Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1224-2018 |
|---|---|
| Recall event | 79394 |
| Product | PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. |
| Product code | JHW |
| Recalling firm | Zimmer Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2019 |
| 510(k) numbers | K122765 |
| FEI number | 1000220733 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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