Class II — BioPro, Inc.
| Recalling firm | BIOPRO, INC. |
|---|---|
| Registered facility | BIOPRO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3 |
| Quantity | 147 total |
| Distribution | US Domestic distribution to Texas and Michigan. |
| Initiated | 2025-09-09 |
| Classified | 2025-10-14 |
| Recall number | Z-0151-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BioPro, Inc. (Z-0151-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97605/
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