Events

Recall of Novation Element

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
    72357
  • Event Risk Class
    Class 2
  • Event Number
    Z-0201-2016
  • Event Date Posted
    2015-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140738
  • 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
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Reason
    Eight (8) pieces did not receive the specified hydroxyapatite (ha) coating.
  • Action
    The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email kaya@exac.com. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative. Any questions contact your Exactech inventory representative at kaya@exac.com or 1-800-392-2832.

Device

Novation Element
  • Model / Serial
    Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: AZ, CO, FL, and MD.
  • Product Description
    Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
  • 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