Device recall
Z-1575-2015: NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-1575-2015 |
|---|---|
| Recall event | 71009 |
| Product | NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur. |
| Product code | JWH |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2015 |
| 510(k) numbers | K960279 |
| 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