Device recall
Z-0590-2016: NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF…
FDA device recall · Class II · Zimmer Manufacturing B.V.
Key facts
| Recall number (Z-number) | Z-0590-2016 |
|---|---|
| Recall event | 72750 |
| Product | NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis. |
| Product code | JWH |
| Recalling firm | Zimmer Manufacturing B.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2016 |
| 510(k) numbers | K933785 |
| 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