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.
FDA Recall Z-2051-2015 · Posted 2015-07-08
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Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeJDS
Date Initiated2015-06-03
Date Terminated2015-09-15
Product Quantity3
Reason for Recall
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Firm 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: [email protected] Number.
If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Root Cause
Employee error
Distribution Pattern
US Distribution to states of: MO and SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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