FDA-Device2016-06-08Class II
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
Orthofix, Inc
Hazard
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.
Sold states
KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
Affected count
36 units
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1881-2016Don't want to check this manually?
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