Events

Recall of Device Recall ConMed Linvatec

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

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
    34438
  • Event Risk Class
    Class 2
  • Event Number
    Z-0179-2007
  • Event Initiated Date
    2005-12-20
  • Event Date Posted
    2006-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43846
  • 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
    Sternum Saw Collet Nut - Product Code KFK
  • Reason
    The sternum saw collet nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. the nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations.
  • Action
    Linvatec will send each consignee a recall package that will include: a 12/20/2005 recall letter and reply form, A product correction instruction sheet , a new Sternum Saw Collet Nut and an assembly manual. Linvatec will also contact each consignee by phone or email. All consignees that have not responded by 30 days after the first mailing will be re-contacted by the firm by mail, phone or email.

Device

Device Recall ConMed Linvatec
  • Model / Serial
    All serial numbers are being recalled.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Mexico, and Canada.
  • Product Description
    ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually.
  • Manufacturer
    Linvatec Corp.

Manufacturer

Linvatec Corp.
  • Manufacturer Address
    Linvatec Corp., 11311 Concept Blvd, Largo FL 33773-4908
  • Source
    USFDA