FDA Device recall Z-1514-2018
Stem Extractor f/Guide Bar, Part number 03.401.072
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Stem Extractor f/Guide Bar, Part number 03.401.072 by Synthes, citing there is a potential for the connection screw of the stem extractor to break.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1514-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-19 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes |
| Distribution | US |
Product
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Reason
There is a potential for the connection screw of the stem extractor to break.
Identifiers
| code_info | 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949 |
|---|
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-1514-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.