Recall Z-0152-2026 ยท LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
BioPro, Inc.
BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR
| 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
| K954768 | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD Biologically Oriented Prostheses, Jan 18, 1996 |