Events

Recall of Device Recall MicroChoice

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Linvatec Corp DBA Linvatec/Hal.

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
    25709
  • Event Risk Class
    Class 2
  • Event Number
    Z-0717-03
  • Event Initiated Date
    2003-01-24
  • Event Date Posted
    2003-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26343
  • 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
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment - Product Code HWE
  • Reason
    The footswitch functions of the left and right foot pedals may be reversed in some units.
  • Action
    The firm telephoned and mailed a Recall Notification letter with response form to all Accounts beginning on 1/24/03. Distributors were asked to subrecall down to the medical facility level. Recalled devices are to be returned to Linvatec for testing.

Device

Device Recall MicroChoice
  • Model / Serial
    Units under recall include the following serial numbers: 3582 thru 3681, 3685 thru 3733, 3739 thru 3766, 3768, 3800 thru 3809 (74 units)
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, worldwide.
  • Product Description
    Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
  • Manufacturer
    Linvatec Corp DBA Linvatec/Hal

Manufacturer

Linvatec Corp DBA Linvatec/Hal
  • Manufacturer Address
    Linvatec Corp DBA Linvatec/Hal, 11311 Concept Blvd., Largo FL 33773
  • Source
    USFDA