Device recall
Z-0437-2013: NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-0437-2013 |
|---|---|
| Recall event | 63544 |
| Product | NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis… |
| Product code | JWH |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2014 |
| 510(k) numbers | K872379 |
| 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