Medical DeviceDec 17, 2014
Skeletal Dynamics Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head recall — FDA Z-0582-2015
Report received where the Align Radial Stem fractured.
Class IIFDA: TerminatedSkeletal Dynamics
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Skeletal Dynamics as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.