Recall Z-0153-2026 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
BioPro, Inc.
BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
| 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
| K872856 | BIOPRO 32MM BALL Biopro, Inc., Aug 17, 1987 |