Device recall
Z-1341-2016: Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS)…
FDA device recall · Class II · Zimmer Manufacturing B.V.
Key facts
| Recall number (Z-number) | Z-1341-2016 |
|---|---|
| Recall event | 73498 |
| Product | Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18 |
| Product code | JWH |
| Recalling firm | Zimmer Manufacturing B.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2017 |
| 510(k) numbers | K113369 |
| FEI number | 1000132037 |
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