Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0148-2026 — 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+6 190

U.S. FDA — Device Enforcement · United States · 2025-09-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0148-2026
Date of alert: 2025-09-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BioPro, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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