| Class 2 Device Recall Stryker Spine Torque Wrench |  |
Date Initiated by Firm | September 24, 2013 |
Date Posted | November 21, 2013 |
Recall Status1 |
Terminated 3 on October 13, 2016 |
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 NJ 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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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