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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes TomoFix Plates

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 Class 2 Recall
Synthes TomoFix Plates
see related information
Date Posted December 10, 2013
Recall Status1 Open
Recall Number Z-0473-2014
Recall Event ID 66582
Premarket Notification
510(K) Number
K023941 
Product Classification Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
Product Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
Code Information J5606-C
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall
A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter dated October 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exchange the old surgical technique guide version J5606-C with the new version J5606-D provided with this notification. Review the revised surgical technique guide (Pages 25 & 26). Forward this Field Safety Notification to anyone in their facility that need to be informed. If the surgical technique guide has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all surgical technique guides have been exchanged. Maintain a copy of this notice. Customers with questions were instructed to contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 2912
Distribution Worldwide Distribution - USA (nationwide) Canada and Mexico
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 = KTT and Original Applicant = SYNTHES (USA)
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