Events

Recall of Proximate Curved and Straight Intraluminal Staplers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery Inc.

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
    79246
  • Event Risk Class
    Class 2
  • Event Number
    Z-0672-2018
  • Event Initiated Date
    2017-10-23
  • 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=161745
  • 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
    Staple, implantable - Product Code GDW
  • Reason
    There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
  • Action
    Ethicon Johnson & Johnson Affiliates in Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter identified the affected product, problems and actions to be taken.

Device

Proximate Curved and Straight Intraluminal Staplers
  • Model / Serial
    CCS25, CCS29
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    China
  • Product Description
    Disposable Curved Circular Staplers || Product Usage: || Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Blue Ash OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA