Recall Z-0151-2026 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BioPro, Inc.
BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
| 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
| K912641 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS Biopro, Inc., Nov 27, 1991 |