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

Recall Z-2064-2015 — Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured

U.S. FDA — Device Enforcement · United States · 2015-06-03 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2064-2015
Date of alert: 2015-06-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Omnilife Science Inc.
Product category: device
Product type: Devices

Reported risk: Product may breach the inner and outer sterile pouches during shipping or handling.

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.

Related