Events

Recall of Device Recall PowerProMax

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

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
    52803
  • Event Risk Class
    Class 1
  • Event Number
    Z-1951-2009
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84037
  • 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
    Battery Single Trigger - Product Code HRX
  • Reason
    There is a potential the devices may self activate for their powerpro, powerpromax, and mpower i handpieces manufactured prior to june 1, 2008.
  • Action
    Consignees were notified via letter by FedEx delivery or equivalent method. If the product has been further distributed the consignee is requested to notify their consignees. The letter indicated the following risk mitigation actions until affected handpieces are returned to the manufacturer for preventive maintenance: 1) Apply supplied label to the identified handpieces by specific serial number, 2) If self-activation is experienced, discontinue use immediately and return to ConMed Linvtec and 3) Advise/remind the consignee to follow the manufacturers preventive maintenance intervals specified in the instructions for use manuals. Direct questions to ConMed Linvatec at 1-800-237-0169. Recall Expansion: New amended customer and distributor letters will be sent to those identified customer/distributor accounts. The letter will address the additional units.

Device

Device Recall PowerProMax
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including United States.
  • Product Description
    PowerProMax PRO5100M Battery Single Trigger, || PowerProMax PRO5200M Battery Two Trigger, || PowerProMax PRO5250M Battery Two-Trigger Standard, || PowerProMax PRO5300M Battery Oscillator, || PowerProMax PRO5400M Battery Reciprocator, and || PowerProMax PRO6200 Battery Single Trigger. || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • Manufacturer Address
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA