Events

Recall of Stryker Medical Cam bearing

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
    52229
  • Event Risk Class
    Class 2
  • Event Number
    Z-0283-2010
  • Event Initiated Date
    2009-08-10
  • Event Date Posted
    2009-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82591
  • 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 brake/steer pedal may seize, resulting in the brakes not working.
  • Action
    Consignees were notified by letter dated August 10, 2009 that Stryker will contact them to upgrade the stretchers within 6 months. The recall was expanded in scope to include additional serial numbers by a second letter dated September 17, 2009, which was issued to additional consignees who had not been previously notified of the recall, as well as the consignees who had been issued the August 10, 2009 letter.

Device

Stryker Medical Cam bearing
  • Model / Serial
    All such parts shipped between 10/30/08 and 03/27/2009.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, Japan, Korea, Latin America, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Singapore, South Africa, Spain, Switzerland, Taiwan, and United Kingdom,
  • Product Description
    Stryker Medical cam bearing service parts, Stryker Medical, Portage, MI; Parts 0753-006-143, 0753-006-130 and 0853-006-130S. || For Wheeled hospital stretcher.
  • 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