Events

Recall of Device Recall ADVANCE DURAMER TIBIAL INSERT

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
    55436
  • Event Risk Class
    Class 2
  • Event Number
    Z-1636-2010
  • Event Initiated Date
    2009-11-24
  • Event Date Posted
    2010-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90852
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The left medial pivot and right medial pivot inserts were co-mingled.
  • Action
    Wright Medical Technology, Inc. issued an "Urgent: Medical Device Voluntary Recall" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm. For further information, contact Wright Medical Technology, Inc. at 1-800-874-5630.

Device

Device Recall ADVANCE DURAMER TIBIAL INSERT
  • Model / Serial
    Lot Number: 679391
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.
  • Product Description
    ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. || Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.
  • 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