Events

Recall of Device Recall Helical Blade Inserter for Trochanteric Fixation NailADVANCED (TFNA)

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
    71492
  • Event Risk Class
    Class 2
  • Event Number
    Z-2091-2015
  • Event Initiated Date
    2015-06-10
  • Event Date Posted
    2015-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137950
  • 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 height of one of the three guiding pins of the helical blade inserter for the tfna is oversized. the helical blade inserter is therefore unable to pass through the blade/screw guide sleeve (part 03.037.017).
  • Action
    A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.

Device

Device Recall Helical Blade Inserter for Trochanteric Fixation NailADVANCED (TFNA)
  • Model / Serial
    Part Number Lot Numbers 03.037.024 T102759
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
  • 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