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[Recalled] rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. — Revision rate identified as higher than other proximal radi

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductrHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Brand / manufacturerHowmedica Osteonics Corp.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2732-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date24 October 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Howmedica Osteonics Corp.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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