Skeletal Dynamics recalls Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilit

Recalled December 17, 2014 · FDA recall Z-0582-2015 · Skeletal Dynamics

Hazard

Report received where the Align Radial Stem fractured. · FDA Class II

Units

1700

Sold at

Nationwide Distribution including GA, NJ, NM, IL, CA, OK, CO, NY, LA, OH, FL, VA, MD, MS, TX, IA, AL, WA, TN, ME, CT, WI, AZ, NE, SC, NC and Puerto Rico.

Description

Report received where the Align Radial Stem fractured.

Product

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.

Manufacturer(s)

Skeletal Dynamics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →