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

Recall Z-2426-2015 — rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.

U.S. FDA — Device Enforcement · United States · 2015-06-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2426-2015
Date of alert
2015-06-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
22288301
Reported risk: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
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.