Events

Recall of Device Recall Manual General Surgery Drill Guide

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthofix, 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
    71262
  • Event Risk Class
    Class 2
  • Event Number
    Z-1819-2015
  • Event Initiated Date
    2015-05-11
  • Event Date Posted
    2015-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137146
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Reason
    There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.
  • Action
    Orthofix sent an Urgent Medical Device Product Advisory Notification letter dated May 11, 2015, to the affected distributors and hospitals. The consignees were directed to inspect thier inventory and perform checks before surgical use of the drill guides. Customers were instructed to provide a copy of the Product Advisory Notification letter if product was further distributed. Customers with questions were instructed to contact their local Orthofix representative and to for returns they should contact Orthofix customer service representative at 888-298-5700.

Device

Device Recall Manual General Surgery Drill Guide
  • Model / Serial
    All lot codes
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
  • Product Description
    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
  • Manufacturer
    Orthofix, Inc

Manufacturer

Orthofix, Inc
  • Manufacturer Address
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Manufacturer Parent Company (2017)
    Orthofix International Nv
  • Source
    USFDA