BioPro, Inc.: 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
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- BioPro, Inc.
- 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
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Domestic distribution to Texas and Michigan.
- Recall initiated
- 2025-09-09
- Code info
- Product ID/UDI-DI 14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096 All lots, all serial numbers
- Product quantity
- 147 total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Port Huron
- State
- MI
- Country
- United States
- Event id
- 97605
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