Events

Recall of Device Recall Terino Square chinStyle IIMedium

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Implantech Associates 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
    66208
  • Event Risk Class
    Class 2
  • Event Number
    Z-2211-2013
  • Event Initiated Date
    2013-08-30
  • Event Date Posted
    2013-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121753
  • 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
    Prosthesis, chin, internal - Product Code FWP
  • Reason
    Implantech initiated a voluntary recall of certain lots of terino square chin-style ii-medicum (lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the tscii-m.
  • Action
    Recall was initiated by sending recall notification letters to customers on 08/30/2013 via a combination of 1st class mail, email, and telephone. The recall notification letter, dated August 30, 2013, informs customers of the reason for recall, product description and codes, instructions on what to do with the recalled product and contact information. Within the recall notification letter, a section is provided for responses and signatures.

Device

Device Recall Terino Square chinStyle IIMedium
  • Model / Serial
    Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
  • Product Description
    Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. || To augment or reconstruct underdeveloped or traumatized mandibular region.
  • Manufacturer
    Implantech Associates Inc

Manufacturer

Implantech Associates Inc
  • Manufacturer Address
    Implantech Associates Inc, 6025 Nicolle St Ste A, Ventura CA 93003-7602
  • Manufacturer Parent Company (2017)
    Implantech Associates Inc
  • Source
    USFDA