Events

Recall of Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.

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

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
    26415
  • Event Risk Class
    Class 2
  • Event Number
    Z-0921-03
  • Event Initiated Date
    2003-06-01
  • Event Date Posted
    2003-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27645
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Non-sterilized product sold as sterile.
  • Action
    Sales representatives were notified on June 1, 2003 and requested to contact their accounts to determine if any product remained on the shelf. Recall letters dated June 12, 2003 were sent to each customer''s risk manager, surgical director and hospital administrator via certified mail

Device

Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral ...
  • Model / Serial
    lot 03030232.
  • Product Classification
    Orthopedic Devices
  • Distribution
    United States, Canada, Italy, Japan and United Kingdom
  • Product Description
    Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
  • Manufacturer
    Stryker Instruments, Instruments Div.

Manufacturer

Stryker Instruments, Instruments Div.
  • Manufacturer Address
    Stryker Instruments, Instruments Div., 4100 E. Milham, Kalamazoo MI 49001
  • Source
    USFDA