Events

Recall of Device Recall EVOLUTION MP TIBIAL BASE, REF ETPKN8SR

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

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
    70477
  • Event Risk Class
    Class 2
  • Event Number
    Z-1249-2015
  • Event Initiated Date
    2015-02-02
  • Event Date Posted
    2015-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133875
  • 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
    Some units of the evolution tibial base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
  • Action
    MicroPort Orthopedics sent an Urgent Action Required letter dated January 29, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock including all consignment stock to determine if they have any affected product. If they have affected product they should return immediately to the MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with "RECALL" for identification and processing. Customers with questions were instructed to contact MPO's Customer Experience Department at 1-866-872-0211. For questions regarding this recall call 901-867-4324.

Device

Device Recall EVOLUTION MP TIBIAL BASE, REF ETPKN8SR
  • Model / Serial
    Lot Numbers: 1560140, 15601401568897, 15601401570896
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
  • Product Description
    EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
  • Manufacturer
    Microport Orthopedics INC.

Manufacturer

Microport Orthopedics INC.