Device recall
Z-1627-2010: Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle…
FDA device recall · Class II · Endotec, Inc.
Key facts
| Recall number (Z-number) | Z-1627-2010 |
|---|---|
| Recall event | 52527 |
| Product | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, Size 3 B-P Type II Talar Ankle Component Catalog… |
| Product code | JWH |
| Recalling firm | Endotec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2013 |
| 510(k) numbers | K842234, K904870 |
| FEI number | 3004553437 |
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