Events

Recall of Device Recall Stryker Disposable StrykeProbe 32cm LTip

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
    45881
  • Event Risk Class
    Class 2
  • Event Number
    Z-0573-2008
  • Event Initiated Date
    2007-11-16
  • Event Date Posted
    2008-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66399
  • 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
    Electrosurgical Suction Tip - Product Code GEI
  • Reason
    Cannot connect: tips have electrodes that are too large to fit monopolar cables and are unusable.
  • Action
    Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.

Device

Device Recall Stryker Disposable StrykeProbe 32cm LTip
  • Model / Serial
    Lot Number: 07297FE2
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

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