Device product
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
Z-1881-2016
Product summary
- Firm
- Orthofix, Inc
- Event
- Event 73978
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-1881-2016
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
Derived failure modes
-
Unknown
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.