Recall Z-0150-2026 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
BioPro, Inc.
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 5
| 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
| K100761 | BIOPRO POLAR HEAD Biopro, Inc., Dec 3, 2010 |