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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Application Instrument Sternal Zip Flex System

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 Class 2 Device Recall Synthes Application Instrument Sternal Zip Flex Systemsee related information
Date Initiated by FirmAugust 13, 2013
Date PostedOctober 30, 2013
Recall Status1 Terminated 3 on August 18, 2016
Recall NumberZ-0114-2014
Recall Event ID 65997
510(K)NumberK110789 
Product Classification Cerclage, fixation - Product Code JDQ
ProductSynthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Code Information Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078 
FEI Number 3005180112
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactSynthes Customer Service
610-719-5000
Manufacturer Reason
for Recall		When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
FDA Determined
Cause 2		Labeling False and Misleading
ActionSynthes sent a Urgent Medical Device Notification dated August 13, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken: This notification is to make you aware of the issue and the importance of completely releasing the tensioning trigger before cutting the implant. Please take the following action: "To ensure your receipt and understanding of this information, Please complete the verification section of this letter and return to Synthes by either of the following methods: " Fax: 1-888-352-9616 or " Scan/email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant.
Quantity in Commerce319
DistributionWorldwide Distribution - US (nationwide) and country of Mexico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JDQ
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