Events

Recall of Plus Orthopedics

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

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
    26326
  • Event Risk Class
    Class 2
  • Event Number
    Z-0017-04
  • Event Initiated Date
    2003-04-17
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27512
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Labeling/packaging mix-up.
  • Action
    Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.

Device

Plus Orthopedics
  • Model / Serial
    Lot 0211.13.4553
  • Product Classification
    Orthopedic Devices
  • Distribution
    TX, CA, VA, ID, NY, UT, FL
  • Product Description
    TC-PLUS Solution Tibial Component-- Symmetric
  • Manufacturer
    Plus Endoprothetik AG

Manufacturer

Plus Endoprothetik AG
  • Manufacturer Address
    Plus Endoprothetik AG, Erlenstrasse 4b, Rotkreuz Switzerland
  • Source
    USFDA