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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Synthes In Situ Bender Cutter Kit Sterile Wide		see related information
Date Posted February 24, 2010
Recall Number Z-0825-2010
Product Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
Code Information All lots.
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions No consumer action necessary
For Additional Information Contact Customer Service
800-479-6329
Reason for
Recall		 There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.
Action An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.
Quantity in Commerce 187 units
Distribution Nationwide Distribution.
 
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