Z-1973-2019 Class II Terminated
FDA device recall Z-1973-2019 was initiated by SpineFrontier, Inc. on Jun 13, 2019 and is designated Class II. Reason for recall: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. The recall status is terminated (terminated May 11, 2020). Affected quantity: 6.
Recall details
- Product Type
- Devices
- Report Date
- Jul 24, 2019
- Initiation Date
- Jun 13, 2019
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product description
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Reason for recall
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
Distribution pattern
The products were distributed to the following US states: AZ, MD, MO, and FL.
Code information
Lot EC20
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1973-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026