Brighton, MI, United States
FlexDex Inc. recalls
1 recall recorded since 2018, most recently on 22 December 2021. 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
- 22 December 2021
- Terminated
- 25 July 2023
- Reason
- The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0531-2022
- 8mm FlexDex Needle Driver, Product Code FD-335 ND
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.