Events

Recall of RF MultiGen, 0406900000; Refurb RF MultiGen, 0406900000U

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
    75485
  • Event Risk Class
    Class 3
  • Event Number
    Z-0584-2017
  • Event Initiated Date
    2016-10-11
  • Event Date Posted
    2016-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150479
  • 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
    Generator, lesion, radiofrequency - Product Code GXD
  • Reason
    Stryker instruments is voluntarily recalling the care instructions/instructions for use packaged with the radiofrequency (rf) multigen¿ generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the multigen¿ cables.
  • Action
    Stryker Instruments initiated a voluntary recall of the RF MultiGen, and Refurb RF MultiGen because the instructions for use contained incorrect instructions on sterilizing the device. Stryker distributed customer notices via certified mail on 10/11/2016. Customer's were instructed to do the following: Immediately review this recall notification. 2. Enclosed was a revised version of the IVS Care Instructions. Please distribute the revised version to the appropriate person or department. 3. Remove and discard any previously distributed IVS Care Instructions or Instructions for Use. 4. Please complete, sign, and return the enclosed Business Reply Form (BRF) acknowledging your receipt and understanding of this notification. 5. Fax the completed BRF to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. Customers with questions can contact: 269 323 7700 .

Device

RF MultiGen, 0406900000; Refurb RF MultiGen, 0406900000U
  • Model / Serial
    RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden VA/DOD:
  • Product Description
    RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
  • 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