Events

Recall of Device Recall Starion Instruments TLS3 35C 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
    55721
  • Event Risk Class
    Class 2
  • Event Number
    Z-1969-2010
  • Event Initiated Date
    2008-02-06
  • Event Date Posted
    2010-07-08
  • 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=91718
  • 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
    Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.
  • Action
    The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees. The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained

Device

Device Recall Starion Instruments TLS3 35C Thermal Ligating Shears
  • Model / Serial
    Model number 132-136D, lot numbers 708027 and 710008, expiration dates 09/21/12 and 10/19/12
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. || Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as 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