Events

Recall of FMsealer Open Shears. Model FM3001

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Domain Surgical, 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
    75627
  • Event Risk Class
    Class 2
  • Event Number
    Z-0690-2017
  • Event Initiated Date
    2016-10-24
  • Event Date Posted
    2016-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150959
  • 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
    Domain surgical, inc. announces a voluntary field action for the fmsealer open shears due to fixed jaw fractures during clincal usage.
  • Action
    Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.

Device

FMsealer Open Shears. Model FM3001
  • Model / Serial
    Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
  • Product Description
    FMsealer Open Shears. Model FM3001
  • Manufacturer
    Domain Surgical, Inc.

Manufacturer

Domain Surgical, Inc.
  • Manufacturer Address
    Domain Surgical, Inc., 1370 S 2100 E, Salt Lake City UT 84108-2244
  • Manufacturer Parent Company (2017)
    OmniGuide Inc.
  • Source
    USFDA