SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1926-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .

Product Classification:

Class II

Date Initiated: March 14, 2013

Date Posted: August 14, 2013

Recall Number: Z-1926-2013

Event ID: 64984

Reason for Recall:

Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.

Status: Terminated

Product Quantity: 8

Code Information:

Lot Number: PM3979

Distribution Pattern:

Distribution only in Texas.

Voluntary or Mandated:

Voluntary: Firm initiated