CoreLink LLC — Class II medical device recall Z-0954-2023
Terminated recall by CoreLink LLC, reported 2023-01-18, distributed nationwide. Specific lots of FLXfit implants have internal components that may have been manufactured using stainless stee
| Recall number | Z-0954-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CoreLink LLC, Fenton, MO, United States |
| Recall initiated | 2022-10-20 |
| Classified | 2023-01-12 |
| Reported by FDA | 2023-01-18 |
| Terminated | 2024-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 18 units |
| Lot numbers | SM129260, SM135217 |
| Model numbers | AT3208 |
Product
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Reason for recall
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
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-0954-2023. 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.