Device recall
Z-0148-2026: BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads…
FDA device recall · Class II · BioPro, Inc.
Key facts
| Recall number (Z-number) | Z-0148-2026 |
|---|---|
| Recall event | 97605 |
| Product | BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD… |
| Product code | LPH |
| Recalling firm | BioPro, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K090208 |
| FEI number | 1832656 |
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