BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 1301
FDA device recall Z-0152-2026 · posted 2025-10-14 · Open, Classified
Recall details
- Recalling firm
- BioPro, Inc.
- 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.
- Action taken
- Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.
- Root cause
- Package design/selection
- Status
- Open, Classified
- Product code
- LZY
- Quantity affected
- 147 total
- Distribution
- US Domestic distribution to Texas and Michigan.
- Date initiated
- 2025-09-09
- Date posted
- 2025-10-14
- Location
- Port Huron, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (K954768) | Biologically Oriented Prostheses | 1996-01-18 |