Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9

FDA Recall Z-0148-2026 · Posted 2025-10-14

Recalling FirmBioPro, Inc.
Recall StatusOpen, Classified
Product CodeLPH
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.

K090208BIOPRO FEMORAL HEADSBiopro, Inc. · 2009-05-22

Official Source

View FDA Recall →

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

↑