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

Recall Z-2481-2019 — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

U.S. FDA — Device Enforcement · United States · 2019-07-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2481-2019
Date of alert
2019-07-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
OMNIlife science Inc.
Product category
device
Product type
Devices
Reported risk: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
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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