Recall Z-1737-2013— SpineFrontier, Inc.

Name: FDA recall Z-1737-2013
Creator: U.S. Food and Drug Administration
Published: 2011-12-30

Class II · Terminated

Class II FDA medical device recall by SpineFrontier, Inc., initiated 2011-12-30, terminated 2014-01-08. It names one FDA 510(k) clearance: K092420. 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.. Reason: 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..

Recalling firm: SpineFrontier, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-12-30
Terminated: 2014-01-08
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K092420 — KRD1 PEDICLE SCREW SYSTEMSpinefrontier, Inc.·cleared 2009-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.