Recall Z-0151-2026
BioPro, Inc. · initiated September 9, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers
Reason for recall
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.
FDA-determined cause: Package design/selection
Action taken
Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.
Details
- Recall number
- Z-0151-2026
- Initiated
- September 9, 2025
- Posted by FDA
- October 14, 2025
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Quantity
- 147 total
- Distribution
- US Domestic distribution to Texas and Michigan.
- Recalling firm
- BioPro, Inc., Port Huron, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0148-2026 Class II | BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part…Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility… | 09/09/2025Open, Classified |
| Z-0149-2026 Class II | BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38…Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility… | 09/09/2025Open, Classified |
| Z-0150-2026 Class II | BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD…Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility… | 09/09/2025Open, Classified |
| Z-0152-2026 Class II | BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012…Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility… | 09/09/2025Open, Classified |
| Z-0153-2026 Class II | BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD…Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility… | 09/09/2025Open, Classified |