Events

Recall of Device Recall Scorpio Series 7000

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
    48995
  • Event Risk Class
    Class 2
  • Event Number
    Z-0115-2009
  • Event Initiated Date
    2008-07-02
  • Event Date Posted
    2008-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72482
  • 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
    Impactor - Product Code HWA
  • Reason
    Stryker orthopaedics became aware that there is a potential inability to release the scorpio series 7000 tibial impactor/extractor from a tibial baseplate during use.
  • Action
    US recall notification (product correction) letters were send out by Federal Express with return receipt on July 2 and 9, 2008. Advisory notices were sent to foreign customers on July 2, 2008. Both letters include a Product Correction Bulletin that instructs all used to lubricate the divide with an approved medical lubricant, especially the extractor shaft and threads. It is recommended that all moving parts be evaluated for functionality and useful service prior to each surgery and instructions on how to perform this process. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5918 for assistance.

Device

Device Recall Scorpio Series 7000
  • Model / Serial
    All Lot Codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide including the US and Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America.
  • Product Description
    Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 || Non Sterile || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || The Impactor/Extractor is used for insertion and removal of a tibial baseplate during total knee arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA