Evans Wedge Disposable Trials — Class II medical device recall Z-1027-2022
Terminated recall by restor3d Inc., reported 2022-05-11, distributed nationwide. During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got
| Recall number | Z-1027-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | restor3d Inc., Durham, NC, United States |
| Recall initiated | 2022-03-30 |
| Classified | 2022-04-29 |
| Reported by FDA | 2022-05-11 |
| Terminated | 2023-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 00840097501574 |
| Lot numbers | 2022010031 |
| Model numbers | 6101-20181018 |
Product
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Reason for recall
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
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-1027-2022. 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.