Synthes Radial Head Prosthesis System — Class II medical device recall Z-1124-2017
Terminated recall by Synthes (USA) Products LLC, reported 2017-02-08, distributed nationwide. There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
| Recall number | Z-1124-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-12-29 |
| Classified | 2017-02-02 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2018-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 50,311 units |
| Model numbers | 01.402.001E, 03.402.006, 03.402.007, 03.402.008, 03.402.009, 03.402.010, 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.106, 03.402.107, 03.402.108, 03.402.109, 03.402.110, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420 and 74 more |
Product
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Reason for recall
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
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-1124-2017. 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.