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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007

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  Class 2 Device Recall Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007 see related information
Date Initiated by Firm September 28, 2012
Date Posted November 13, 2012
Recall Status1 Terminated 3 on September 21, 2015
Recall Number Z-0277-2013
Recall Event ID 63446
510(K)Number K082650  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007.

Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.
Code Information Part number 390.007, Lot number 6800599
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.
FDA Determined
Cause 2		 Labeling mix-ups
Action Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated September 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Verification Form via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this notice.
Quantity in Commerce 8
Distribution Nationwide Distribution-including the states of CA, MN, NC, and TN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = SYNTHES (USA)
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