Recall Z-0148-2026 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
BioPro, Inc.
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 FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056
| Date | Oct 14, 2025 (initiated Sep 9, 2025) |
| Status | Open, Classified |
| Reason | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. |
| Root cause | Package design/selection |
| Action | Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro. |
| Quantity | 147 total |
| Distribution | US Domestic distribution to Texas and Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090208 | BIOPRO FEMORAL HEADS Biopro, Inc., May 22, 2009 |