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FDAOctober 24, 2017device

#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

howmedica osteonicshowmedica

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. — Recall Details · AllClear