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Open, Classified

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

FDA Recall Z-0151-2026 · Posted 2025-10-14

Recalling FirmBioPro, Inc.
Recall StatusOpen, Classified
Product CodeLZO
Date Initiated2025-09-09
Product Quantity147 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.

Firm Action

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

Distribution Pattern

US Domestic distribution to Texas and Michigan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912641BIOPRO ZIRALLOY MODULAR FEMORAL HEADSBiopro, Inc. · 1991-11-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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