medical Class II Updated 2018-08-15

Howmedica Osteonics Corp. recalls radial head implant #4 (Sterile packed). Orthopedic implant

Recalled Product

radial head implant #4 (Sterile packed). 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

Distribution: Nationwide (United States)
Lot/Code Info: RHA-H4
View official government recall

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