Events

Recall of Device Recall Proximate Linear Cutter

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

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
    26386
  • Event Risk Class
    Class 3
  • Event Number
    Z-0985-03
  • Event Initiated Date
    2003-05-21
  • Event Date Posted
    2003-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27597
  • 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
    Instrument, Manual, Surgical, General Use - Product Code MDM
  • Reason
    The linear cutters may have unsharpened knife blades that may prevent the device from operating properly.
  • Action
    The firm contacted their customers by FedEx on 5/21/2003.

Device

Device Recall Proximate Linear Cutter
  • Model / Serial
    Lot Number: T4W32E, Exp 2008-03.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals and distributors located nationwide.
  • Product Description
    Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery
  • Manufacturer Address
    Ethicon Endo-Surgery, 4545 Creek Rd, Cincinnati OH 45242
  • Source
    USFDA