Events

Recall of Device Recall Knee replacement system,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho Development 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
    57705
  • Event Risk Class
    Class 2
  • Event Number
    Z-1742-2011
  • Event Initiated Date
    2011-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97055
  • 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
    Components of a replacement knee system could be mislabeled.
  • Action
    The firm, Ortho Development, sent a "Field Notification Memo" date January 7, 2011 to its customers. The memo described the product, problem and action to be taken. The customers were instructed to promptly return any remaining parts of the listed product; locate all the parts in their inventory; identify any of the listed parts that may have been used in surgery; verify the quantity they have on hand and the quantity used in surgery and reconcile them with the quantity sent; if discrepancy exists, notify customer service resolution; prepare items for return and contact customer service to obtain RMA number. Once reconciled, arrangements would be made for sending new inventory and the return of unused parts. If you have any questions regarding this issue, please notify Regulatory Affairs Manager at (801) 619-3450.

Device

Device Recall Knee replacement system,
  • Model / Serial
    Lot Number: 670676
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
  • Product Description
    UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 || The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Manufacturer Parent Company (2017)
    Ortho Development Corporation
  • Source
    USFDA