Recall Z-0375-2014— Stryker Spine

Class II FDA medical device recall by Stryker Spine, initiated 2013-09-24, terminated 2016-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.. Reason: Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening..

Recalling firm

Stryker Spine

Classification

Class II

Status

Terminated

Initiated

2013-09-24

Terminated

2016-10-13

Firm location

Allendale, NJ, United States

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