innovasis, inc
1 recall on record
I
Innovasis, Inc — Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.
FDAHealth