Events

Recall of Device Recall Starion Instruments 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
    55043
  • Event Risk Class
    Class 2
  • Event Number
    Z-2239-2010
  • Event Initiated Date
    2010-03-09
  • Event Date Posted
    2010-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89744
  • 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/cauterization and accessories - Product Code GEI
  • Reason
    The starion instruments thermal ligating shears (stls) 35c and the starion thermal ligating shears (stls) 23c may turn on and remain on without the finger button being depressed. the devices may also work intermittently, incorrectly indicating the device is 'on".
  • Action
    Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..

Device

Device Recall Starion Instruments Thermal Ligating Shears
  • Model / Serial
    STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022  STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
  • Product Description
    The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting 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