[Recalled] Radio Capitellum Small, Left. 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 radial head repla
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. |
|---|---|
| Brand / manufacturer | Howmedica Osteonics Corp. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2694-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 24 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.