Non-Sterile Double Ended Trial Kit — Class II medical device recall Z-1026-2022
Terminated recall by restor3d Inc., reported 2022-05-11, distributed nationwide. Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
| Recall number | Z-1026-2022 |
|---|---|
| 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 | 14 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00840097504506 |
| Lot numbers | 2022030005 |
| Model numbers | 6110-N01-KTS01 |
Product
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Reason for recall
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
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-1026-2022. 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.