Device recall
Z-1325-2015: NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size…
FDA device recall · Class II · Zimmer Trabecular Metal Technology, Inc.
Key facts
| Recall number (Z-number) | Z-1325-2015 |
|---|---|
| Recall event | 70605 |
| Product | NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating… |
| Product code | MBH |
| Recalling firm | Zimmer Trabecular Metal Technology, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2015 |
| 510(k) numbers | K040487 |
| FEI number | 3005751028 |
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