Device recall
Z-1006-2019: NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial…
FDA device recall · Class II · Zimmer Trabecular Metal Technology, Inc.
Key facts
| Recall number (Z-number) | Z-1006-2019 |
|---|---|
| Recall event | 82125 |
| Product | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total… |
| Product code | JWH |
| Recalling firm | Zimmer Trabecular Metal Technology, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2020 |
| 510(k) numbers | K024161 |
| 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