Events

Recall of Device Recall ACL Workstation slider

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

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
    46350
  • Event Risk Class
    Class 2
  • Event Number
    Z-1107-2008
  • Event Initiated Date
    2007-12-07
  • Event Date Posted
    2008-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67224
  • 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
    Arthoscope - Product Code HRX
  • Reason
    Slider lock failure - the acl workstation slider, a component of the acl workstation, does not consistently lock into the acl workstation base.
  • Action
    On January 9, 2008, sales representatives were notified via telephone. All consignees were mailed an Urgent: Device Removal notice, dated January 10, 2008. The firm requested that any affected inventory in stock be quarantined and returned to Stryker Endoscopy for destruction. A response form with return postage was included with notification mailed to all consignees.

Device

Device Recall ACL Workstation slider
  • Model / Serial
    Lot Numbers: 55-059169, 55-059965, 45165M-3, 44252M-1, and 44660M-1.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - including USA states of South Carolina, Oregon, Michigan, Nebraska, Maryland, California, New Mexico, Ohio, Texas, West Virginia, Massachusetts, and Florida and countries of Canada, Mexico, Hong Kong, Argentina, Brazil, France, Germany, Greece, Spain, India, Italy, Columbia, Switzerland, Poland, Sweden, Australia, and Netherlands.
  • Product Description
    Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138
  • Source
    USFDA