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U.S. Department of Health and Human Services

Class 2 Device Recall InSitu Bender Cutter Kit Narrow Sterile

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 Class 2 Recall
InSitu Bender Cutter Kit Narrow Sterile
see related information
Date Posted June 01, 2009
Recall Status1 Terminated on December 15, 2009
Recall Number Z-1249-2009
Recall Event ID 51422
Premarket Notification
510(K) Number
K021458 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.
Code Information Catalog number 530.522S - Lot number TM00324 exp 4/8/10
Recalling Firm/
Manufacturer
Synthes Spine
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 40 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
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