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

Recall Z-2372-2024 — UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038

U.S. FDA — Device Enforcement · United States · 2024-06-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2372-2024
Date of alert
2024-06-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327032338
Reported risk: Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
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.

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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.