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Howmedica Osteonics Corp. recalls rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius i
Recalled August 15, 2018 · FDA recall Z-2704-2018 · Howmedica Osteonics
Hazard
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. · FDA Class II
Units
66
Sold at
Distribution US Nationwide.
Description
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.
Product
rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →