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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
InSitu Bender Cutter Kit Wide Sterile		see related information
Date Posted June 01, 2009
Recall Number Z-1248-2009
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, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Lynne Lewis
610-719-5000
Reason for
Recall		 The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
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
 
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