Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71440
  • Event Risk Class
    Class 2
  • Event Number
    Z-2051-2015
  • Event Initiated Date
    2015-06-03
  • Event Date Posted
    2015-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137807
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Nail, fixation, bone - Product Code JDS
  • Reason
    A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
  • 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.

Device

Device Recall TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILSEX
  • Model / Serial
    Part # 04.004.000, lot # 7950994
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: MO and SC.
  • Product Description
    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.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA