Reported Jul 24, 2019 · Terminated
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
SpineFrontier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SpineFrontier, Inc. · 350 Main St · Malden, MA · 02148-5089
Is this the product you have?
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
- Lot codes and dates
- Lot EC20
- Amount recalled
- 6
Where it was sold
Why it was recalled
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
This product could cause temporary or reversible health problems — stop using it.
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