Events

Recall of Device Recall Knee joint replacement

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by United Orthopedic Corporation.

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
    79321
  • Event Risk Class
    Class 2
  • Event Number
    Z-1128-2018
  • Event Initiated Date
    2017-11-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161889
  • 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
    Uoc received a customer compliant report from our distributor on october 31, 2017 which stated that contents of the package do not match the product labeling.
  • Action
    Urgent Field safety notice was distributed to customers on November 24, 2017 via e-mail. The letter identified the affected product, problem and actions to be taken. For further questions, please call (949) 328-3366.

Device

Device Recall Knee joint replacement
  • Model / Serial
    Lot number 17B621AX
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
  • Product Description
    U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, || 11mm Thick Catalogue number 2303-3032 || The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
  • Manufacturer
    United Orthopedic Corporation

Manufacturer

United Orthopedic Corporation
  • Manufacturer Address
    United Orthopedic Corporation, No. 57 Park Avenue 2, Science Park, Hsinchu Taiwan
  • Manufacturer Parent Company (2017)
    United Orthopedic Corp.
  • Source
    USFDA