Events

Recall of Device Recall NOVATION MODULAR DRILL BIT

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

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
    62140
  • Event Risk Class
    Class 2
  • Event Number
    Z-2365-2012
  • Event Initiated Date
    2012-01-24
  • Event Date Posted
    2012-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110251
  • 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
    Bit, drill - Product Code HTW
  • Reason
    Exactech inc. of gainesville, fl is recalling their novation modular drill bits after the devices were reported to have been used by end user while in a non-sterile condition.
  • Action
    The firm, Exactech, Inc., called the lone customer on January 24, 2012 to discuss the product, problem and actions to be taken. The customer was instructed to return all unused devices and associated packaging.

Device

Device Recall NOVATION MODULAR DRILL BIT
  • Model / Serial
    Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA state of: Arkansas only
  • Product Description
    REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA