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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Application Instrument for Sternal ZIPFIX

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  Class 2 Device Recall Synthes Application Instrument for Sternal ZIPFIX see related information
Date Initiated by Firm July 22, 2015
Date Posted August 27, 2015
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-2475-2015
Recall Event ID 71834
510(K)Number K110789  
Product Classification Cerclage, fixation - Product Code JDQ
Product Synthes Application Instrument for Sternal ZIPFIX; indications for use include 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 Number: 03.501.080 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 8130898 8130975 8145793 8159386 8166417 8186954 8207769 8209190 8215969 8215999 8241958 8290959 8290968
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
610-719-6500
Manufacturer Reason
for Recall		 The end cap may loosen and detach making the instrument non-functional. No injuries reported.
FDA Determined
Cause 2		 Device Design
Action Urgent recall notification letters, dated July 22, 2015 were sent to end users and consultants to inform them of the issue, the associated risks, and provided instructions to return affected devices along with the response form.
Quantity in Commerce 451
Distribution Nationwide 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 = JDQ and Original Applicant = SYNTHES (USA)
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