Stem Extractor f/Guide Bar — Class II medical device recall Z-1514-2018
Terminated recall by Synthes, Inc., reported 2018-05-02, distributed nationwide. There is a potential for the connection screw of the stem extractor to break.
| Recall number | Z-1514-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2018-03-19 |
| Classified | 2018-04-25 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH |
| Quantity | 31 |
| Reason classes | device malfunction |
| Model numbers | 03.401.072 |
Product
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Reason for recall
There is a potential for the connection screw of the stem extractor to break.
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-1514-2018. 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.