Events

Recall of Ultra Power Burs, Sterile, Single-Use.

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
    29916
  • Event Risk Class
    Class 2
  • Event Number
    Z-0041-05
  • Event Initiated Date
    2004-08-26
  • Event Date Posted
    2004-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34765
  • 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
    Arthroscope - Product Code HRX
  • Reason
    The pouch containing the sterile product is not completely seal on all products. therefore , the sterility of the device is questionable.
  • Action
    Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.

Device

Ultra Power Burs, Sterile, Single-Use.
  • Model / Serial
    All product with an expiration date between August 2004 and August 2009.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to 492 customers throughout the United States, and 301 customers internationally.
  • Product Description
    Ultra Power Burs, Sterile, Single-Use.
  • Manufacturer
    Linvatec Corp.

Manufacturer

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