Events

Recall of Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Starion Instruments.

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
    55750
  • Event Risk Class
    Class 2
  • Event Number
    Z-1972-2010
  • Event Initiated Date
    2008-06-26
  • Event Date Posted
    2010-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91719
  • 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, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
  • Action
    The firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose. If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.

Device

Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears
  • Model / Serial
    Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA || Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
  • Manufacturer
    Starion Instruments

Manufacturer

Starion Instruments
  • Manufacturer Address
    Starion Instruments, 775 Palomar Ave, Sunnyvale CA 94085-2915
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    USFDA