Device recall
Z-1600-2012: REF 90-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked…
FDA device recall · Class II · Zimmer Inc.
Key facts
| Recall number (Z-number) | Z-1600-2012 |
|---|---|
| Recall event | 61468 |
| Product | REF 90-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 14 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the… |
| Product code | JWH |
| Recalling firm | Zimmer Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2014 |
| 510(k) numbers | K003910, K892800, K933785, K951185 |
| 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