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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 4.5MM TI VALCP CRVD Condylar Plate/6H/159MM/RTSTER

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  Class 2 Device Recall Synthes 4.5MM TI VALCP CRVD Condylar Plate/6H/159MM/RTSTER see related information
Date Initiated by Firm May 29, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-0401-2014
Recall Event ID 66723
510(K)Number K110354  
Product Classification condylar plate fixation Implant - Product Code JDP
Product Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Code Information part 04.124.406S, lot 3771678.
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		 A plate was inadvertently released to a sales consultant that was restricted for sale.
FDA Determined
Cause 2		 Employee error
Action Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received. The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use. For questions the surgeon was instructed to call 800-620-7025. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 1
Distribution US Distribution in Colorado.
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 = JDP and Original Applicant = SYNTHES USA
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