Events

Recall of Device Recall TransFx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Immedica 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
    26320
  • Event Risk Class
    Class 2
  • Event Number
    Z-0907-03
  • Event Initiated Date
    2003-02-10
  • Event Date Posted
    2003-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27505
  • 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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite - Product Code LXT
  • Reason
    Mislabeled; wrong identification number on pin.
  • Action
    Recall letter was sent on 2/10/2003 to Zimmer Patient Care Division. The letter states that Zimmer is to conduct a sub-recall to their customers to account for the 127 pieces sent to them.

Device

Device Recall TransFx
  • Model / Serial
    Catalog No./Part No./Ref.No. -- 00-4453-34-08. Lot Number: 70209800
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government accounts.
  • Product Description
    TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread.
  • Manufacturer
    Immedica Inc

Manufacturer

Immedica Inc
  • Manufacturer Address
    Immedica Inc, 100 Passaic Ave., Chatham NJ 07928
  • Source
    USFDA