Seminole, FL, United States
VGI Medical, LLC recalls
1 recall recorded since 2018, most recently on 9 April 2018. 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
- 9 April 2018
- Terminated
- 21 August 2020
- Reason
- IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
- Distribution
- Distributed to MI, FL, and NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2100-2018
- VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
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.