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

Recall Z-0582-2015 — Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservat

U.S. FDA — Device Enforcement · United States · 2014-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0582-2015
Date of alert: 2014-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Skeletal Dynamics
Product category: device
Product type: Devices

Reported risk: Report received where the Align Radial Stem fractured.

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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