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

Recall Z-1633-2015 — Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies enco

U.S. FDA — Device Enforcement · United States · 2014-08-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1633-2015
Date of alert: 2014-08-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Howmedica Osteonics Corp.
Product category: device
Product type: Devices

Reported risk: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

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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