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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 4.5 mm LCP Curved Condylar Plate

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  Class 2 Device Recall Synthes 4.5 mm LCP Curved Condylar Plate see related information
Date Initiated by Firm July 30, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on August 31, 2015
Recall Number Z-0409-2014
Recall Event ID 66418
510(K)Number K041911  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Synthes 4.5 mm LCP Curved Condylar Plate

Intended for buttressing multifragmentary distal femur fractures.
Code Information Part No. 02.001.324, lot no. 6900823
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 Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
FDA Determined
Cause 2		 Process control
Action Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 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 returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 13
Distribution Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.
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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