Device recall
Z-0612-2020: REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999…
FDA device recall · Class II · Enztec Limited
Key facts
| Recall number (Z-number) | Z-0612-2020 |
|---|---|
| Recall event | 84217 |
| Product | REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE |
| Product code | HWA |
| Recalling firm | Enztec Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2023 |
| FEI number | 3004641308 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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