Events

Recall of Device Recall DRILOK THREADED CANNULA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    79978
  • Event Risk Class
    Class 2
  • Event Number
    Z-2057-2018
  • Event Initiated Date
    2017-12-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164124
  • 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
    Surgical cannulaes & depth gauge kit for athroscopic pocedures - Product Code PPR
  • Reason
    Inadvertent shipment of expired units.
  • Action
    The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 12/27/2017 to its customers via mail on about 12/28/2017. Customers were initially notified via phone on 12/21/2017 and 12/22/2017. The letter described the product, problem and actions to be taken. The customers were instructed to inform those individuals in the organization who need to be aware of the recall; examine stock for affected devices; quarantine and discontinue use of recalled device; complete and return the Business Reply Form to Stryker Endoscopy via fax (408-855-6314) or email (endorecall@stryker.com), and if affected product is on hand segregate it and contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). If you have any questions, contact Director of Regulatory Affairs and Clinical Science at 408-754-2664 or email: to endorecall@stryker.com.

Device

Device Recall DRILOK THREADED CANNULA
  • Model / Serial
    Lot No. 14239AG2, UPC 07613327055795.  The expiration date marked on the box is August 2018, but it should be August 2016.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to Massachusetts only..
  • Product Description
    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. || The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
  • Manufacturer
    Stryker Corporation

Manufacturer

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