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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Synthes

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  Class 2 Device Recall DePuy Synthes see related information
Date Initiated by Firm October 19, 2015
Date Posted November 14, 2015
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-0276-2016
Recall Event ID 72469
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 Synthes Application Instrument for Sternal ZIPFIX, Part Number 03.501.080. Lot Numbers 3783913, 7516728, 7606881, 7659168, 7666085, 7671934, 7689244, 7694377, 7720599, 7738572, 7738573, 7740498, 7767497, 7803768, 7806881, 7818677, 7818682, 7821672, 7827088, 7831855, 7833606, 8068078, 8130898, 8145793, 8207769, and 8215969. 
Recalling Firm/
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact
Manufacturer Reason
for Recall
Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.
FDA Determined
Cause 2
Device Design
Action Communication to the accounts having record of receiving this product was sent on October 19, 2015.
Quantity in Commerce 267
Distribution Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
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)