Events

Recall of Device Recall Mitek Profile

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
    25698
  • Event Risk Class
    Class 3
  • Event Number
    Z-0699-03
  • Event Initiated Date
    2003-02-28
  • Event Date Posted
    2003-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26293
  • 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
    Screw, Fixation, Bone - Product Code HWC
  • Reason
    Mislabeled product: screw length incorrectly labeled may contain a 30 mm instead of 20 mm.
  • Action
    Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.

Device

Device Recall Mitek Profile
  • Model / Serial
    Lot Number: 0301594
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,
  • Product Description
    Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head || Product Reference No.: 230420
  • Manufacturer
    Mitek Worldwide

Manufacturer

Mitek Worldwide
  • Manufacturer Address
    Mitek Worldwide, 249 Vanderbilt Drive, Norwood MA 02062
  • Source
    USFDA