Recall Z-0153-2026
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 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
Codes / lots: Product ID/UDI-DI 14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096 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-0153-2026
- Initiated
- September 9, 2025
- Posted by FDA
- October 14, 2025
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- 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-0151-2026 Class II | BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL…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 |