Events

Recall of Device Recall Synthes Trochanteric Fixation Nail

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, 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
    66409
  • Event Risk Class
    Class 2
  • Event Number
    Z-0474-2014
  • Event Initiated Date
    2013-07-30
  • Event Date Posted
    2013-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122353
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Certain lots of trochanteric fixation nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were instructed to take the following steps: Complete the attached Verification Section at the end of the letter by checking the appropriate box indicating no affected product has been located. Return the documents to Synthes by fax to 610-251-9005 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Device

Device Recall Synthes Trochanteric Fixation Nail
  • Model / Serial
    Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
  • Product Description
    Synthes Trochanteric Fixation Nail || As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

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