10G DIRECT SINGLE — Class II medical device recall Z-1715-2021
Terminated recall by Zavation, reported 2021-06-09, distributed nationwide. Products distributed as sterile may not have been adequately sterilized
| Recall number | Z-1715-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zavation, Flowood, MS, United States |
| Recall initiated | 2021-03-25 |
| Classified | 2021-06-01 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Reason classes | sterility |
| Lot numbers | 20051288 |
Product
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Reason for recall
Products distributed as sterile may not have been adequately sterilized
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-1715-2021. 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.