rHead Standard Extended Stem — Class II medical device recall Z-2704-2018
Terminated recall by Howmedica Osteonics Corp., reported 2018-08-15, distributed nationwide. Revision rate identified as higher than other proximal radial head replacement devices based on literature rev
| Recall number | Z-2704-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2017-10-24 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2023-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 66 |
Product
rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2704-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.