Events

Recall of Device Recall Eye Surgery Stryker Medical Stretchers Model 1089

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
    59201
  • Event Risk Class
    Class 2
  • Event Number
    Z-2864-2011
  • Event Initiated Date
    2011-07-19
  • Event Date Posted
    2011-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102121
  • 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 firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa.
  • Action
    Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included. For additional information call (269) 389-6604.

Device

Device Recall Eye Surgery Stryker Medical Stretchers Model 1089
  • Model / Serial
    Model: 1089 Lots: 1102034587, 1102034588, 1102034589, 1102034590, and 1102034591.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.
  • Product Description
    Eye Surgery Stryker Medical Stretchers Model 1089 || Intended to transport patients in a horizontal position.
  • 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