SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1737-2013)

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:

KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.

Product Classification:

Class II

Date Initiated: December 30, 2011

Date Posted: July 24, 2013

Recall Number: Z-1737-2013

Event ID: 64989

Reason for Recall:

One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.

Status: Terminated

Product Quantity: 2 rods

Code Information:

Lot Number: 002876-007R

Distribution Pattern:

USA Nationwide Distribution including the state of TX

Voluntary or Mandated:

Voluntary: Firm initiated