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U.S. Department of Health and Human Services

Class 2 Device Recall THOR

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  Class 2 Device Recall THOR see related information
Date Initiated by Firm October 02, 2009
Date Posted November 24, 2009
Recall Status1 Terminated 3 on January 23, 2013
Recall Number Z-0440-2010
Recall Event ID 53606
510(K)Number K073437  
Product Classification spinal implant component - Product Code KWQ
Product Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.5 x 25MM, spinal implant component
Code Information Catalog number 48036525, all lots
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8287
Manufacturer Reason
for Recall
Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.
FDA Determined
Cause 2
Device Design
Action Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
Quantity in Commerce 388
Distribution Nationwide
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 = KWQ and Original Applicant = STRYKER SPINE
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