Synapse System 3 — Class II medical device recall Z-0223-2020
Terminated recall by Synthes (USA) Products LLC, reported 2019-11-06, distributed in NJ. The subject product measures 4.0mm in diameter instead of 3.5mm.
| Recall number | Z-0223-2020 |
|---|---|
| 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 | 2019-09-16 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-04-24 |
| Distributed | NJ |
| Quantity | 6 |
| Model numbers | 04.615.026 |
Product
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Reason for recall
The subject product measures 4.0mm in diameter instead of 3.5mm.
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-0223-2020. 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.