Events

Recall of Device Recall Stryker Medical 1105 Prime 5th Wheel

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
    59214
  • Event Risk Class
    Class 2
  • Event Number
    Z-2927-2011
  • Event Initiated Date
    2011-07-19
  • Event Date Posted
    2011-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102514
  • 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
    Stryker medical has determined that some prime brake pad assembly components were manufactured with brake shoes that did not meet specifications. accordingly some brake shoes used within the prime brake pad assembly may wear prematurely, over the life of the product. reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.
  • Action
    Stryker Medical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 18, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected stretchers and to test the brakes. If the brakes are found to be inoperable, customers are instructed to remove the stretchers from service and contact the firm at 800-STRYKER, option 3. Additionally, customers are instructed not to put the stretchers back in service until they are repaired by the firm's field service representative. For units with properly functioning brakes, the letter also instructs the user to test the brakes before each use until the unit has been serviced. A post card was enclosed to confirm receipt of the letter. Questions or concerns may be addressed by calling Stryker at 269-389-6604.

Device

Device Recall Stryker Medical 1105 Prime 5th Wheel
  • Model / Serial
    Lots 1104032654, 1104030037, 1104030100, 1104030101, 1104030102, 1104030103, 1104030116, 1104032614, 1104032587, 1104032588, 1104032545, 1104032546, 1104032547, 1104032548, 1104032549, 1104030030, 1104030055, 1104030210 and 1104032611.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, CA, FL, GA, HI, IL, MA, MN, MO, NH, NJ, NV, NY, PA, RI, TX, UT, and VA and the country of THE NETHERLANDS.
  • Product Description
    Stryker Medical Stretcher Model 1105 Prime 5th Wheel || A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

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