Events

Recall of Device Recall Inion GTR Membrane systemTacks

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

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
    76638
  • Event Risk Class
    Class 2
  • Event Number
    Z-1478-2017
  • Event Initiated Date
    2017-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153713
  • 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
    Barrier, synthetic, intraoral - Product Code NPK
  • Reason
    Aluminum pouch seal was noticed to be defective (slightly open).
  • Action
    Inion sent an Urgent: Medical Device Recall Notification letter dated March 1, 2017. The recall letter asked customers to inspect the aluminum pouch seals, remove any devices with defective seals from sales stock, and to return the product to Inion. The customers were also asked to inform Inion Oy of the outcome of their inspections using a feedback form. For further questions call (954) 659-9224.

Device

Device Recall Inion GTR Membrane systemTacks
  • Model / Serial
    Lot Number 1604006, 1505007, 1503039
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to : FL and NC.
  • Product Description
    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. || Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
  • Manufacturer
    Inion Ltd.

Manufacturer

Inion Ltd.
  • Manufacturer Address
    Inion Ltd., Laakarinkatu 2, FIN-33520 Tampere Finland
  • Source
    USFDA