FDA Device recall Z-2679-2018
rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial…
- FDA Device
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial… by Howmedica Osteonics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2679-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-24 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason
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.
Identifiers
| code_info | 310-2012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2679-2018%22
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