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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Matrix 5.5.mm Left and Right Coronal Bender

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  Class 2 Device Recall Synthes Matrix 5.5.mm Left and Right Coronal Bender see related information
Date Initiated by Firm June 22, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-0391-2014
Recall Event ID 66416
Product Classification Instrument, bending or contouring - Product Code HXP
Product Synthes Matrix 5.5.mm Left and Right Coronal Bender

Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
Code Information Parts 03.632.040 and 03.632.041 with various lot nos.  Item Lot Number Number   03.632.040 T935338 03.632.040 T939100 03.632.040 T945062 03.632.040 T953982 03.632.040 T956310 03.632.040 T959990 03.632.040 T959995     Item Lot Number Number   03.632.041 T935343 03.632.041 T939105 03.632.041 T939755 03.632.041 T945067 03.632.041 T952750 03.632.041 T956315 03.632.041 T960000 03.632.041 T960005 
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.
FDA Determined
Cause 2		 Component design/selection
Action Synthes sent an Urgent Notice: Medical Device Recall letter dated June 22, 2013 to users and sales reps. The letter identified the affected product, problem and actions to be taken. For questions call 610-719-5450.
Quantity in Commerce 209
Distribution Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
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.
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