Events

Recall of TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.

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

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
    32837
  • Event Risk Class
    Class 3
  • Event Number
    Z-0126-06
  • Event Initiated Date
    2005-02-22
  • Event Date Posted
    2005-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40913
  • 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
    Labeling discrepancy.
  • Action
    Firm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return.

Device

TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
  • Model / Serial
    Exp Date of 2011. No serial number. Lot number 0411.13.6556.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    NY
  • Product Description
    TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • Manufacturer Address
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA