medical Class II Updated 2018-08-15

Howmedica Osteonics Corp. recalls rHead Recon Extended Stem Size 1. Orthopedic implant for re

Recalled Product

rHead Recon Extended Stem 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

Distribution: Nationwide (United States)
Lot/Code Info: 410-0300
View official government recall

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