Events

Recall of Device Recall Exactech Spine, Large Set Screw

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
    71528
  • Event Risk Class
    Class 2
  • Event Number
    Z-2059-2015
  • Event Initiated Date
    2009-03-06
  • Event Date Posted
    2015-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138110
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Reason
    Incorrect thread form on the screw.
  • Action
    Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.

Device

Device Recall Exactech Spine, Large Set Screw
  • Model / Serial
    Catalog Number 28202, Lot Number AS05107
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of FL, GA, IL, NY, TX, and WA.
  • Product Description
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. || Intended to provide immobilization and stabilization of spinal segments.
  • 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