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U.S. Department of Health and Human Services

Class 2 Device Recall Xia 3 AntiTorque Key

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  Class 2 Device Recall Xia 3 AntiTorque Key see related information
Date Initiated by Firm January 12, 2012
Date Posted June 05, 2012
Recall Status1 Terminated 3 on March 21, 2013
Recall Number Z-1706-2012
Recall Event ID 61766
510(K)Number K071373  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026.

Product Usage: :
Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct.
Code Information Lot Codes (510k exempt): 07F116, 07F117, 085525, 086577, 086578, 087232, 087233, 088604.
Recalling Firm/
Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
Manufacturer Reason
for Recall
Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Stryker Spine sent an Urgent Product Recall letter dated January 12, 2012 with an attached Customer Response forms via FEDEX to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory to identify the affected product and return using the prepaid mailing label provided. The letter asked customers to complete the Customer Response Form and fax to 201.760.8370. For questions call 201.760.8298.
Quantity in Commerce 95 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = STRYKER SPINE