Howmedica Osteonics Corp. recalls Lateral Assembly, Radial Implant, Size 1 Orthopedic implant
Recalled Product
Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Hazard / Issue
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Issued by
FDA
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