Device recall
Z-0123-2015: The Persona Tibial Articular Surface Inserter is a sterilizable instrument…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-0123-2015 |
|---|---|
| Recall event | 69354 |
| Product | The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate. |
| Product code | JWH |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2015 |
| 510(k) numbers | K113369 |
| FEI number | 1000220733 |
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