Device recall
Z-0495-2015: PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained…
FDA device recall · Class II · Zimmer CAS
Key facts
| Recall number (Z-number) | Z-0495-2015 |
|---|---|
| Recall event | 69630 |
| Product | PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. |
| Product code | JWH |
| Recalling firm | Zimmer CAS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2015 |
| 510(k) numbers | K131409 |
| FEI number | 3003714383 |
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