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Recall Observatory FDA recall evidence

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

April 27, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    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.