BioPro, Inc.: Device Recall

Recall Details

Recall Number

Z-0153-2026

Classification

Class II

Product Type

Device

Recalling Firm

BioPro, Inc.

Status

Ongoing

Date Initiated

09/09/2025

Location

Port Huron, MI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

147 total

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.

Product Description

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

Distribution Pattern

US Domestic distribution to Texas and Michigan.

Other Recalls by BioPro, Inc.

• Class II: Risk 09/09/2025
  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.
• Class II: Risk 09/09/2025
  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.
• Class II: Risk 09/09/2025
  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.
• Class II: Risk 09/09/2025
  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.
• Class II: Risk 09/09/2025
  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.

View all recalls by BioPro, Inc. →