Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Align Radial Stems Recalled by Skeletal Dynamics Due to Report received where the Align Radial Stem fractured.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Skeletal Dynamics directly.
Affected Products
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 conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.
Quantity: 1700
Why Was This Recalled?
Report received where the Align Radial Stem fractured.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Skeletal Dynamics
Skeletal Dynamics has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report