Events

Recall of Device Recall Gladiator Bipolar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology 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
    37250
  • Event Risk Class
    Class 2
  • Event Number
    Z-0573-2007
  • Event Initiated Date
    2007-01-03
  • Event Date Posted
    2007-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50194
  • 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
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented - Product Code KWY
  • Reason
    Product specification failure which could result in improper locking of the cup onto the femoral head.
  • Action
    The firm initiated the recall by telephoning its distributors on January 3, 2007 to request the return of the products. They followed with letters (mailed 1/15/07) to hospitals, implanting surgeons, and distributors requesting return of the product and informing them of the revision surgery that was a result of the problem.

Device

Device Recall Gladiator Bipolar
  • Model / Serial
    Lot Nos.: 106379830, 106382095, 116389421
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Japan
  • Product Description
    Wright Medical Technology, Gladiator¿ Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm O.D., use with 36 mm Head
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Road, PO Box 100, Arlington TN 38002-0100
  • Source
    USFDA