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.
This recall has been terminated (originally issued July 8, 2015).
- Company
- Synthes, Inc.
- Recall Initiated
- June 3, 2015
- Posted
- July 8, 2015
- Terminated
- September 15, 2015
- Recall Number
- Z-2051-2015
- Quantity
- 3
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Distribution
US Distribution to states of: MO and SC.
Lot / Code Info
Part # 04.004.000, lot # 7950994
Root Cause
Employee error
Action Taken
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.