Events

Recall of Device Recall Scorpio PS Femoral Waffle and LFIT

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
    50101
  • Event Risk Class
    Class 2
  • Event Number
    Z-0795-2010
  • Event Initiated Date
    2007-07-30
  • Event Date Posted
    2010-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74724
  • 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
    Stryker orthopaedics became aware that a box packaged and labeled as a scorpio ps femoral waffle (no post) with lfit, may actually contain a scorpio femoral waffle (with post) and lfit.
  • Action
    Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm. For further information, contact Stryker Orthopaedics at (201) 831-5825.

Device

Device Recall Scorpio PS Femoral Waffle and LFIT
  • Model / Serial
    Scorpio (no post) with LFIT: Product code 72-4107-L; Lot code: JKWMHD;
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States and France.
  • Product Description
    Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. || Intended for cemented application to replace the articulating surface of the distal femur.
  • 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