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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes In Situ Bender Cutter Kit Sterile Wide

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 Class 2 Recall
Synthes In Situ Bender Cutter Kit Sterile Wide
see related information
Date Posted February 24, 2010
Recall Status1 Terminated on October 06, 2010
Recall Number Z-0825-2010
Recall Event ID 54238
Premarket Notification
510(K) Number
K021458 
Product Classification Plate, Fixation, Bone - Product Code HRS
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
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
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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