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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Screw Inserter

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  Class 2 Device Recall Synthes Screw Inserter see related information
Date Initiated by Firm September 21, 2015
Date Posted October 15, 2015
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-0126-2016
Recall Event ID 72243
510(K)Number K131548  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Code Information Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407 
Recalling Firm/
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
FDA Determined
Cause 2
Device Design
Action DePuy Synthes sent an urgent notice of medical device recall letter dated September 21, 2015, to all affected customers to notify them about the issue, the potential risks, and to provide instructions for return of the completed response form and affected devices. Customers with questions were instructed to call 610-719-5450.
Quantity in Commerce 793
Distribution US Nationwide Distribution
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 = HSB and Original Applicant = SYNTHES (USA) PRODUCTS, LLC