Events

Recall of Device Recall Metrx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Warsaw Orthopedic, 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
    32511
  • Event Risk Class
    Class 2
  • Event Number
    Z-0992-05
  • Event Initiated Date
    2005-06-20
  • Event Date Posted
    2005-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40309
  • 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
    arthroscopy - Product Code HRX
  • Reason
    The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
  • Action
    Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.

Device

Device Recall Metrx
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.
  • Product Description
    Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
  • Manufacturer
    Warsaw Orthopedic, Inc.

Manufacturer

Warsaw Orthopedic, Inc.
  • Manufacturer Address
    Warsaw Orthopedic, Inc., 2500 Silveus Xing, Warsaw IN 46582-8598
  • Source
    USFDA