Events

Recall of Device Recall Titanium Trochanteric Fixation Nail (TFN)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

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
    78958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0604-2018
  • Event Initiated Date
    2017-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160966
  • 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
    The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
  • Action
    The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned.

Device

Device Recall Titanium Trochanteric Fixation Nail (TFN)
  • Model / Serial
    Lot H302839, Expiration Date 31Jan2026
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, GA, PA, UT and Canada
  • Product Description
    11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA