Events

Recall of UltraCongruent Tibial Insert Model 0214703 || Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm

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

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
    30807
  • Event Risk Class
    Class 2
  • Event Number
    Z-0540-05
  • Event Initiated Date
    2005-01-04
  • Event Date Posted
    2005-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36638
  • 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
    Knee tibial insert is mislabeled completely as different device.
  • Action
    PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.

Device

UltraCongruent Tibial Insert Model 0214703 || Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
  • Model / Serial
    All of specific lot 044843
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    California, Idaho, Illinois, Wisconsin, Oregon
  • Product Description
    UltraCongruent Tibial Insert Model 0214703 || Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
  • Manufacturer
    Plus Orthopedics

Manufacturer

Plus Orthopedics
  • Manufacturer Address
    Plus Orthopedics, 10188 Telesis Ct, San Diego CA 92121
  • Source
    USFDA