Events

Recall of Ultrapower Bur

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
    38631
  • Event Risk Class
    Class 2
  • Event Number
    Z-0711-2008
  • Event Initiated Date
    2007-08-09
  • Event Date Posted
    2008-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54061
  • 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
    bur - Product Code GFF
  • Reason
    Compromised sterility: conmed linvatec medical devices packaged within a certain peel pouch sterile package may have compromised sterility due to an improper seal.
  • Action
    Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email.

Device

Ultrapower Bur
  • Model / Serial
    Lot Numbers: BBD14805 BBD14542 BBD14804 00949613 BBD08721 BBD11468 BBD14258 BBD15139 BBD16978 BBC91085 BBD08725 BBD11465 BBD13560 BBD14265 BBD14533 BBD17117 BBD18411 BBD08940 BBD11470 BBD13564 BBD14680 BBD14711 BBD18412 BBD08939 BBD15429 BBD15591 BBD16681 BBD14944 BBD17632 BBD17835 BBD08961 BBD17399 BBD08935 BBD14264 BBD15416 BBD17423 BBD14935 BBD17832 BBD08942 BBD14261 BBD17633 BBD08448 BBD13158 BBD16029 BBD08943 BBD13565 BBD16122 BBD17627 BBD08389 BBD14260 BBD15401 BBD16652 BBD11471 BBD14266 BBD14658 BBD17631 BBD17836 BBD08443 BBD13567 BBD14747 BBD08445 BBD13569 BBD17896 BBD08959 BBD17626 00950532 BBD08936 BBD13570 BBD08972 BBD15179 BBD08473 BBD13571 BBD14242 BBD15398 BBD17550 BBD08957 BBD08974 BBD16653 BBD08482 BBD17609 BBD08442 BBD15426 BBD16654 BBD08976 BBD14955 BBD08452 BBD09167 BBD14257 BBD16045 BBD08446 BBD15191 BBD16655 BBD08483 BBD15393 BBD16656 BBD08952 BBD11469 BBD16658 BBD17602 BBC89881 BBD08444 BBD16657 BBD17442 BBD08531 BBD15084 BBD17629 BBD14255 BBD14538 BBC92804 BBD15644 BBD16832
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773
  • Manufacturer
    Linvatec Corp.

Manufacturer

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