Events

Recall of Device Recall Stryker PowerPRO

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
    36149
  • Event Risk Class
    Class 2
  • Event Number
    Z-1513-06
  • Event Initiated Date
    2006-08-29
  • Event Date Posted
    2006-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48076
  • 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
    Ambulance Cot - Product Code FPO
  • Reason
    The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out.
  • Action
    Consignees were notified of the recall via letter dated 8/29/06. Included with the letter were replacement bolts for each cot and installation instructions, but the customer was given the option of contacting the recalling firm for installation.

Device

Device Recall Stryker PowerPRO
  • Model / Serial
    All units with a serial number lower than 060739380. (units manufactured between 1 Oct 2005 and 15 July 2006)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including USA and countries of Canada, China, Germany and Switzerland.
  • Product Description
    Stryker Power-PRO Powered Ambulance Cot, Model 6500.
  • 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