Fenton, MO, United States
CoreLink LLC recalls
1 recall recorded since 2018, most recently on 20 October 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 October 2022
- Terminated
- 20 August 2024
- Reason
- Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0954-2023
- CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.