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U.S. Department of Health and Human Services

Class 2 Device Recall TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILSEX

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  Class 2 Device Recall TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILSEX see related information
Date Initiated by Firm June 03, 2015
Date Posted July 08, 2015
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-2051-2015
Recall Event ID 71440
510(K)Number K040762  
Product Classification Nail, fixation, bone - Product Code JDS
Product TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Code Information Part # 04.004.000, lot # 7950994
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
FDA Determined
Cause 2		 Employee error
Action The firm, Depuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" notification letter, dated June 3, 2015, to direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove the affected lots from your stock; If you DO have any of the identified devices, please take the following steps: ¿¿ Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA)Complete and Return the Verification Section with the product to: ¿¿ Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. ¿¿ Send a copy of the completed Verification Section even if you do not have any product to DePuy Synthes by: ¿¿ Fax: (610) 430-7083 or ¿¿ Scan/email: Fieldaction@synthes.com Number. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce 3
Distribution US Distribution to states of: MO and SC.
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 = JDS and Original Applicant = SYNTHES (USA)
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