Recall Z-0152-2026
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 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 CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36
Codes / lots: Product ID/UDI-DI 13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296 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-0152-2026
- Initiated
- September 9, 2025
- Posted by FDA
- October 14, 2025
- Product code
- LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- 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-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 |