Events

Recall of Device Recall SCORPIOFLEX CR TIBIAL TRIAL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    56332
  • Event Risk Class
    Class 2
  • Event Number
    Z-1684-2011
  • Event Initiated Date
    2010-07-13
  • Event Date Posted
    2011-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93263
  • 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 LXH
  • Reason
    Stryker orthopaedics became aware that there is the potential for the scorpio t72 tibial insert trials to be oversized by a maximum of .024" (0.6mm).
  • Action
    Stryker Howmedica Osteonics Corp.sent Urgent Product Correction letters Correction letters dated July 23, 2010, via Federal Express to all affected customers. were sent to all Stryker Branches on July 23, 2010 via Federal Express. Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America sites were sent letters on July 26, 2010 by Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Correction Acknowledgement Form by fax as soon as possible to 201-831-6069. For any questions customers were to call 201-972-2100 or 201-831-5028.

Device

Device Recall SCORPIOFLEX CR TIBIAL TRIAL
  • Model / Serial
    T72-5-0308A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 8 MM T72-5-0310A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 10 MM T72-5-0312A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 12 MM T72-5-0315A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 15 MM T72-5-0318A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 18 MM T72-5-0321A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 21 MM T72-5-0324A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 24 MM T72-5-0508A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 8 MM T72-5-0510A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 10 MM T72-5-0512A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 12 MM T72-5-0515A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 15 MM T72-5-0518A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 18 MM T72-5-0521A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 21 MM T72-5-0524A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 24 MM T72-5-0708A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 8 MM T72-5-0710A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 10 MM T72-5-0712A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 12 MM T72-5-0715A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 15 MM T72-5-0718A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 18 MM T72-5-0721A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 21 MM T72-5-0724A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 24 MM T72-5-0908A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 8 MM T72-5-0910A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 10 MM T72-5-0912A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 12 MM T72-5-0915A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 15 MM T72-5-0918A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 18 MM T72-5-0921A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 21 MM T72-5-0924A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 24 MM T72-5-1108A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 8 MM T72-5-1110A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 10 MM T72-5-1112A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 12 MM T72-5-1115 SCORPIO SUPERFLEX PS TIB.TRIAL, SIZE 11, 15 MM T72-5-1115A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 15 MM T72-5-1118A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 18 MM T72-5-1121A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 21 MM T72-5-1124A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 24 MM All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.
  • Product Description
    SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA