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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Spine Torque Wrench

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 Class 2 Recall
Stryker Spine Torque Wrench
see related information
Date Posted November 21, 2013
Recall Status1 Open
Recall Number Z-0375-2014
Recall Event ID 66657
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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.
Code Information Medical Device Listing Number E207315 1) XIA Torque Wrench Catalog # 03807028 Lot # 127510, 092793, 097089, 11E038, 11E039, 11E040, 11E041, 123746, 127179, &12D012 2) XIA 3 Torque Wrench Catalog # 48237028 Lot # 11E042, 11E044, 11E047, 098525, 118823, 11E043, 11E045, 11E046, 11E048, 127647, R127647, 12A646, & R12A646 3) XIA Elegance Short Torque Wrench Catalog # 482397028 Lot # 11A957, 11E035, 11E036, R11E036, & 121098 4) Mantis Redux Torque Wrench Reference Number 48287028 Lot # 098401, 125708, 125709, 127051 & 12A641
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
For Additional Information Contact Mr. Daniel Roberts
201-760-8298
Manufacturer Reason
for Recall
Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
FDA Determined
Cause 2
DESIGN: Process Design
Action Stryker sent an Urgent Medical Device Removal Notification letter dated September 25, 2013, with product accountability forms to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital locations to identify any affected product, reconcile any Torque Wrenches with Catalog Number with Lot Numbers referenced in the letter. Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance at 855-632-9049 or you email it to Spine-RegulatoryActions@Stryker.com. Customers were asked to return the affected product using the enclosed mailing label to: RECALL RA 2013-105 Stryker Spine 59 Route 17 South, Allendale, New Jersey 07401 branches/agencies, the field and surgeons via Fed Ex on starting on 9/24/2013. For questions regarding this recall call 201-760-8298. Stryker sent another Urgent Medical Device Removal Notification Letter dated 1/29/2014 which included additional lots and one product.
Quantity in Commerce 220 US units; 431 OUS units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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