SpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk
SpineFrontier, Inc. is recalling six A-CIFT SoloFuse Fixed Angle Drivers because they may bind when advancing fixation screws.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that poses a risk of harm during a procedure, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
SpineFrontier, Inc. is recalling six units of the A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01. The recall involves component part numbers 14-32107-01 and 14-32106, specifically lot EC20.
The recall is being issued because there is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. This mechanical issue could interfere with the intended use of the device during a medical procedure.
The affected products were distributed to the following US states: Arizona (AZ), Maryland (MD), Missouri (MO), and Florida (FL). Healthcare facilities and providers who have received these devices should stop using them and contact SpineFrontier, Inc. for instructions on return or replacement.
The recalled product
- Product
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot EC20
Distribution
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