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U.S. Department of Health and Human Services

Class 2 Device Recall Xia Dual Anterior Staple

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  Class 2 Device Recall Xia Dual Anterior Staple see related information
Date Initiated by Firm April 12, 2007
Date Posted June 26, 2009
Recall Status1 Terminated 3 on June 29, 2009
Recall Number Z-1525-2009
Recall Event ID 52093
510(K)Number K060361  
Product Classification Spinal Pedicle Fixation Orthosis - Product Code NKB
Product Stryker Xia Dual Anterior Staple;
Non Sterile; Catalog number 03820115;
Manufactured by Stryker Spine SAS, Cestas, France;
Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430

Single use device sterilized prior to use. For anterior/anterolateral and posterior noncervical pedicle and non-pedicle fixation for the following: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, psudoartrosis, and failed previous fusion.
Code Information lot code HJ3
Recalling Firm/
Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Tiffani Rogers
Manufacturer Reason
for Recall
Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.
FDA Determined
Cause 2
Error in labeling
Action Market Withdrawal letters were sent to Stryker branches who received product on April 13, 2007 by Federal Express. The letters asked that they examine their inventory and hospital locations to identify the implant; reconcile these implants on the attached Product Accountability Form and fax a copy to (201) 760-8456; retrieve and return the affected implants; and contact their Stryker Customer Service rep to re-order the product that they are returning as part of the regulatory action.
Quantity in Commerce 38 in US
Distribution 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