Malden, MA, United States
SpineFrontier, Inc. recalls
1 recall recorded since 2018, most recently on 13 June 2019. 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
- 13 June 2019
- Terminated
- 11 May 2020
- Reason
- There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
- Distribution
- The products were distributed to the following US states: AZ, MD, MO, and FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1973-2019
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
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.