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

Recall Z-2714-2018 — #1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

U.S. FDA — Device Enforcement · United States · 2017-10-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2714-2018
Date of alert
2017-10-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Reported risk: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-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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