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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 NAILSEXsee related information
Date Initiated by FirmJune 03, 2015
Date PostedJuly 08, 2015
Recall Status1 Terminated 3 on September 15, 2015
Recall NumberZ-2051-2015
Recall Event ID 71440
510(K)NumberK040762 
Product Classification Nail, fixation, bone - Product Code JDS
ProductTITANIUM 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
FEI Number 3005180112
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactCustomer 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
ActionThe 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 Commerce3
DistributionUS Distribution to states of: MO and SC.
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 = JDS
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