Events

Recall of Device Recall Gyrus ACMI Diego Elite Tubeset

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

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
    71238
  • Event Risk Class
    Class 2
  • Event Number
    Z-1753-2015
  • Event Initiated Date
    2015-05-08
  • Event Date Posted
    2015-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136950
  • 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
    Potential lack of sterility assurance.
  • Action
    The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary.

Device

Device Recall Gyrus ACMI Diego Elite Tubeset
  • Model / Serial
    Lot Number: JC24165
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
  • Product Description
    Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Manufacturer Address
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA