Drug recall
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
FDA recall event 91109 · Class II · CoreLink LLC
Key facts
| Event ID | 91109 |
|---|---|
| Recall numbers | Z-0954-2023 |
| Recalling firm | CoreLink LLC |
| Product type | Devices |
| Products | CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 20, 2022 |
| Report date | Jan 18, 2023 |
| Termination date | Aug 20, 2024 |
| City | Fenton |
| State | MO |
| Country | United States |
| FEI number | 3006494201 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: