Events

Recall of Device Recall Mitek Products

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

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
    26503
  • Event Risk Class
    Class 3
  • Event Number
    Z-1005-03
  • Event Initiated Date
    2003-06-16
  • Event Date Posted
    2003-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27789
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Mislabeled -incorrect screw size. the unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 x 25mm.
  • Action
    Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory.

Device

Device Recall Mitek Products
  • Model / Serial
    Lot Number: 0207146 Exp 2007-7
  • Product Classification
    Orthopedic Devices
  • Distribution
    CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain
  • Product Description
    Profile 8 x 20 mm Cannulated Interference Screw Round Head || Catalog Number: 230420
  • Manufacturer
    Mitek Worldwide

Manufacturer

Mitek Worldwide
  • Manufacturer Address
    Mitek Worldwide, 249 Vanderbuilt Drive, Norwood MA 02063
  • Source
    USFDA