FDA-Device2014-12-17Class II
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.
Skeletal Dynamics
Hazard
Report received where the Align Radial Stem fractured.
Sold states
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.
Affected count
1700
Manufactured in
8905 Sw 87th Ave Ste 201, N/A, Miami, FL, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2015Don't want to check this manually?
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