Orthofix, Inc: Medical Device Recall in 2016 - (Recall #: Z-1881-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.

Product Classification:

Class II

Date Initiated: April 27, 2016

Date Posted: June 8, 2016

Recall Number: Z-1881-2016

Event ID: 73978

Reason for Recall:

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.

Status: Terminated

Product Quantity: 36 units

Code Information:

All lots

Distribution Pattern:

KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA

Voluntary or Mandated:

Voluntary: Firm initiated