Events

Recall of Device Recall Super SecurFit

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
    51180
  • Event Risk Class
    Class 2
  • Event Number
    Z-0557-2010
  • Event Initiated Date
    2009-01-14
  • Event Date Posted
    2009-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78919
  • 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
    hip prosthesis - Product Code MEH
  • Reason
    Stryker orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
  • Action
    Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.

Device

Device Recall Super SecurFit
  • Model / Serial
    Catalog Number: J6054-XXXX; All lots codes with an expiry prior to Aug. 2013.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.
  • Product Description
    Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; || Arc Deposited, V40 taper || Not for use with 16mm heads.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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