Events

Recall of Device Recall 6381 M1 Cot Fastener

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Division 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
    79817
  • Event Risk Class
    Class 2
  • Event Number
    Z-1599-2018
  • Event Initiated Date
    2018-03-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163576
  • 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 operations manual and maintenance manual are missing various warnings and contain incorrect information.
  • Action
    On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com 3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form. 4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.

Device

Device Recall 6381 M1 Cot Fastener

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA