Device recall
Z-0545-2013: Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-0545-2013 |
|---|---|
| Recall event | 63690 |
| Product | Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of… |
| Product code | JWH |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2014 |
| 510(k) numbers | K113369 |
| FEI number | 1000220733 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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