SpineFrontier, Inc. recalls KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking

Recalled July 24, 2013 · FDA recall Z-1737-2013 · SpineFrontier

Hazard

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. · FDA Class II

Units

2 rods

Sold at

USA Nationwide Distribution including the state of TX

Description

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.

Product

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.

Manufacturer(s)

SpineFrontier, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →