MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm… — Class II medical device recall Z-0349-2020
Terminated recall by Synthes (USA) Products LLC, reported 2019-11-20, distributed in AR. Modified outside of approved manufacturing process
| Recall number | Z-0349-2020 |
|---|---|
| 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 | 2019-09-05 |
| Classified | 2019-11-08 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2020-06-23 |
| Distributed | AR |
| Quantity | 9 units |
Product
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle
Reason for recall
Modified outside of approved manufacturing process
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-0349-2020. 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.