Events

Recall of Device Recall 24mm Rotating CMount Coupler

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
    47463
  • Event Risk Class
    Class 2
  • Event Number
    Z-1558-2008
  • Event Initiated Date
    2008-03-31
  • Event Date Posted
    2008-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69537
  • 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
    General & plastic surgery laparoscope - Product Code GCJ
  • Reason
    The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. the coupler is part of the camera system and affects the ability to focus.
  • Action
    Only one customer had all of the defective couplers. The firm called this customer on March 27, 2008, and asked that the 28 couplers remaining in their possession be returned.

Device

Device Recall 24mm Rotating CMount Coupler
  • Model / Serial
    Model Number: 1088-020-121S2 Lot Numbers:  Shipped: 07L046134, 07L046144, 07L046154, 07L046164, 07L046184, 07L046194, 07L046214, 07L046224, 07L046234, 07L046244, 07L046254, 07L046274, 07L046284, 07L046294, 07L046304, 07L046324, 07L046334, 07L046344, 07L046364, 07L046374, 07L046384, 07L046394, 07L046404, 07L046414, 07L046424, 07L046454, 07L046464, and 07L046474.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was delivered to one consignee in Iowa.
  • Product Description
    24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

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