Events

Recall of Device Recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom)

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
    73403
  • Event Risk Class
    Class 2
  • Event Number
    Z-1184-2016
  • Event Initiated Date
    2016-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144122
  • 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, powered - Product Code INK
  • Reason
    The hydraulic jack assemblies (pn: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. the oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. testing was done to evaluate the jacks with incorrect oil and leak events we.
  • Action
    On 2/5/2016, URGENT MEDICAL DEVICE NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m.-5 p.m. (ET).

Device

Device Recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom)
  • Model / Serial
    The hydraulic jack assemblies (Part numbers: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) used as service parts on Stretchers assembled from 8/28/15 - 8/29/15
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.
  • Product Description
    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) || Powered stretcher
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

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