Reported Jun 8, 2016 · Terminated
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx…
Orthofix, 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: Orthofix, Inc · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
- Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
- Lot codes and dates
- All lots
- Amount recalled
- 36 units
Where it was sold
Why it was recalled
There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
This product could cause temporary or reversible health problems — stop using it.
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