FDA Device recall Z-1124-2017
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint re…
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint re… by Synthes Usa Products, citing there is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1124-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-29 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
Identifiers
| code_info | Part Numbers: 03.402.006 03.402.007 03.402.008 03.402.009 03.402.010 03.402.018 03.402.020 03.402.022 03.402.0…Part Numbers: 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 03.402.422 03.402.424 03.402.426 03.402.428 03.402.618 03.402.620 03.402.622 03.402.624 03.402.626 03.402.628 03.402.701 03.402.710 03.402.711 03.402.712 03.402.716 03.402.717 03.402.718 03.402.719 03.402.720 03.402.721 03.402.722 03.402.723 03.402.724 03.402.725 03.402.726 03.402.727 03.402.728 03.402.729 03.402.730 03.402.731 03.402.732 03.402.733 03.402.734 03.402.735 03.402.740 03.402.741 03.402.744 04.402.006S 04.402.007S 04.402.008S 04.402.009S 04.402.010S 04.402.026S 04.402.027S 04.402.028S 04.402.029S 04.402.030S 09.402.018S 09.402.020S 09.402.022S 09.402.024S 09.402.026S 09.402.028S 09.402.218S 09.402.220S 09.402.222S 09.402 |
|---|
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-1124-2017%22
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