Device recall
Z-1378-2022: Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos…
FDA device recall · Class II · Waldemar Link GmbH & Co. KG (Mfg Site)
Key facts
| Recall number (Z-number) | Z-1378-2022 |
|---|---|
| Recall event | 90477 |
| Product | Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11. |
| Product code | JWH |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212742 |
| FEI number | 3003386935 |
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