FDA-Device2018-08-15Class II
rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Howmedica Osteonics Corp.
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.
Sold states
Distribution US Nationwide.
Affected count
216
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2692-2018Don't want to check this manually?
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