Events

Recall of Device Recall Stryker ACM bowl without cartridge

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

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
    46340
  • Event Risk Class
    Class 2
  • Event Number
    Z-1106-2008
  • Event Initiated Date
    2008-01-10
  • Event Date Posted
    2008-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67211
  • 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
    bone cement accessory - Product Code JDZ
  • Reason
    Sterility may be compromised, as the packaging may have channels in the packaging seal.
  • Action
    Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.

Device

Device Recall Stryker ACM bowl without cartridge
  • Model / Serial
    Lot Numbers: 05167CG2, 05192012, 05223012 and 06335012.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.
  • Product Description
    Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA