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U.S. Department of Health and Human Services

Class 2 Device Recall InSitu Bender Cutter Kit Wide Sterile

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  Class 2 Device Recall InSitu Bender Cutter Kit Wide Sterile see related information
Date Initiated by Firm December 18, 2008
Date Posted June 01, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-1248-2009
Recall Event ID 51422
510(K)Number K021458  
Product Classification craniofacial system instrument - Product Code HRS
Product Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.
Code Information Catalog number 530.521S - Lot number TM00322 exp 4/13/11
Recalling Firm/
Manufacturer		 Synthes Spine
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Lynne Lewis
610-719-5000
Manufacturer Reason
for Recall		 The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
FDA Determined
Cause 2		 Process control
Action All affected Synthes CMF Sales Consultants were notified of the Medical Device Recall by phone on 12/19/08 and by letter sent via return receipt email on 12/22/08. All affected hospitals were notified by letter mailed on 12/22/08 via USPS certified mail.
Quantity in Commerce 26 units
Distribution Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT
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 = HRS and Original Applicant = SYNTHES (USA)
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