Events

Recall of Device Recall Endoscopic Tarsal Tunnel Decompression

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instratek, 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
    72748
  • Event Risk Class
    Class 2
  • Event Number
    Z-0469-2016
  • Event Initiated Date
    2015-11-24
  • Event Date Posted
    2015-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142098
  • 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
    Arthroscopic surgery component - Product Code HRX
  • Reason
    The sterile blade will not fit into the handle provided with the ettd system.
  • Action
    Instratek contacted customers by phone call either by direct contact or voice mail message on November 23, 2015. that a recall was being initiated. Formal letters were sent via UPS to the Customers annoucing the recall on November 24, 2015. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product,please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You should contact lnstratek's Customer service for a return authorization number and further instructions for return of unused product.

Device

Device Recall Endoscopic Tarsal Tunnel Decompression
  • Model / Serial
    Lot number MDHZ620
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to the states: TX, UT, NY and CO.
  • Product Description
    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
  • Manufacturer
    Instratek, Incorporated

Manufacturer

Instratek, Incorporated
  • Manufacturer Address
    Instratek, Incorporated, 15200 Middlebrook Dr Ste G, Houston TX 77058-1217
  • Manufacturer Parent Company (2017)
    Instratek Incorporated
  • Source
    USFDA