Events

Recall of Device Recall Stryker Model 6100 M1 Ambulance Cot

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical 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
    56628
  • Event Risk Class
    Class 2
  • Event Number
    Z-0328-2011
  • Event Initiated Date
    2010-05-15
  • Event Date Posted
    2010-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94146
  • 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
    stretcher, wheeled - Product Code FPO
  • Reason
    The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures.
  • Action
    Stryker Medical sent an Urgent Medical Device Alert letter dated May 15, 2010 to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter stated that there is a possibility for fatigue related failures of certain components of the cot and that a Stryker representative will visit the firm to correct the device. A representative from Stryker field service would contact the customer to perform the device corrections, free of charge. Immediate Action required by the customer: Locate the ambulance cots listed in this notice. Return the enclosed post card to confirm receipt of this notification. If any of the cots listed in the letter were loaned or sold the customer was to forward a copy of the notice to the new users and advise Stryker of their new location. If the customer disposed of any of the affected stretchers and they were no longer in use, customers were to advise Stryker of their obsolescence by providing the serial numbers For any questions or comments regarding this issue, please call (800) 869-0770, ext. 6902.

Device

Device Recall Stryker Model 6100 M1 Ambulance Cot
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldlwide Distribution - US including AZ, CA, CO, FL, LA, MS, NC, NJ, OH, PA, and TN and the countries of Australia, China, France, Germany, Hong Kong, Italy, Japan, New South Wales, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.
  • Product Description
    Stryker M1 Ambulance cot, Model 6100, Stryker Medical, Kalamazoo, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA