Device recall
Z-0449-2016: Label reading in part as: "NexGen System, Complete Knee Solution; Reference…
FDA device recall · Class II · Zimmer Manufacturing B.V.
Key facts
| Recall number (Z-number) | Z-0449-2016 |
|---|---|
| Recall event | 72729 |
| Product | Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy… |
| Product code | JWH |
| Recalling firm | Zimmer Manufacturing B.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 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