Howmedica Osteonics Corp. recalls rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in…

Recall date

October 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2688-2018

FDA classification

Class II

Brand / firm

Howmedica Osteonics Corp.

Sold / distributed

Distribution US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.