Events

Recall of ADVANCE (R) CANAL FILLING STEM EXTENSION (13mm)

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
    53538
  • Event Risk Class
    Class 3
  • Event Number
    Z-0493-2010
  • Event Initiated Date
    2009-09-22
  • Event Date Posted
    2009-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85740
  • 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
    Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Product Code MBH
  • Reason
    Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. the absence of alloying elements results in an area with less strength. for those instances where the product has been implanted, there is the potential increased risk of failure for these patients.
  • Action
    Wright Medical initiated the recall of the product on September 22, 2009 by contacting the distributors by telephone followed with letters addressed to the hospitals and surgeons dated October 9, 2009. At the firm, Customer Service is the contact for return instructions and replacement inventory. This phone number is 800-238-7117. Other questions regarding this matter are directed to 800-874-5630.

Device

ADVANCE (R) CANAL FILLING STEM EXTENSION (13mm)
  • Model / Serial
    Lot number: 098705612
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece
  • Product Description
    ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA