FDA Device recall Z-0954-2023
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
- FDA Device
- Class II
- terminated
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 by Corelink, citing specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0954-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-20 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Corelink |
| Distribution | US |
Product
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Reason
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Identifiers
| code_info | UDI/DI M725AT32080, Lot Codes: SM135217, SM129260 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2023%22
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