Events

Recall of Device Recall DriLok Disposable Cannula

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
    50525
  • Event Risk Class
    Class 2
  • Event Number
    Z-0868-2009
  • Event Initiated Date
    2008-12-01
  • Event Date Posted
    2009-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75698
  • 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
    Arthroscope and accessories (obturator and cannula) - Product Code HRX
  • Reason
    Leak: leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.
  • Action
    Recall initiated 12/01/2008, Sales representatives were notified via telephone and e-mail. Product advisories entitled ""Urgent: Device Removal" and dated December 1, 2008, were sent to all consignees. All unused product is to be returned to the firm. For further information, please contact Stryker Endoscopy by telephone at 408-754-2124.

Device

Device Recall DriLok Disposable Cannula
  • Model / Serial
    Lot numbers 08135AG2 through 08294AG2.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switzerland, and UK.
  • Product Description
    Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. || The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically. || Manufactured by Stryker Endoscopy Puerto Rico
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA