Events

Recall of Device Recall ADVANCE TIBIAL WEDGE AUGMENT

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
    54677
  • Event Risk Class
    Class 2
  • Event Number
    Z-1215-2010
  • Event Initiated Date
    2010-02-19
  • Event Date Posted
    2010-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89000
  • 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 polymer/metal/polymer semi-constrained cemented prosthesis. - Product Code JWH
  • Reason
    The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).
  • Action
    The firm initiated their recall of the product by letter on February 19, 2010. The notification letters were addressed to distributors, hospital administrators, and surgeons with a fax back response form. The letter described the affected product and reason for the recall. Customers were instructed to examine their inventory and return the recalled product to Wright Medical Technology, Inc. Customers may contact Customer Service by calling 1-800-238-7117 for return instructions and replacement inventory. Direct questions regarding this matter to Wright Medical Technology, Inc. by calling 1-800-874-5630.

Device

Device Recall ADVANCE TIBIAL WEDGE AUGMENT
  • Model / Serial
    Lot numbers: 087441267 and 097441268.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil.
  • Product Description
    ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. || The device is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease, 2)inflammatory joint disease, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed and 5) treatment of fractures that are unmanageable using other techniques. (For cement use only).
  • 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