Events

Recall of Device Recall Stryker stretcher, Model 1231.

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
    37214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0234-2008
  • Event Initiated Date
    2004-11-15
  • Event Date Posted
    2007-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65439
  • 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 - Product Code FPO
  • Reason
    The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.
  • Action
    The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.

Device

Device Recall Stryker stretcher, Model 1231.
  • Model / Serial
    All stretchers with serial numbers beginning with 0309 through 0505.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
  • Product Description
    Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231, Stryker Medical, Portage, MI 49002
  • 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