Events

Recall of 4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alphatec Spine, 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
    70958
  • Event Risk Class
    Class 2
  • Event Number
    Z-1547-2015
  • Event Initiated Date
    2015-04-10
  • Event Date Posted
    2015-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135722
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    During a field audit it was discovered by an employee that a 16mm trestle luxe screw has been both laser marked and labeled as a 14mm trestle luxe screw (4.0mm variable angle, self-drilling hexalobe screw, 14mm). as a result the firm recalling the affected lots codes for this mislabeling.
  • Action
    Alphatec Spine sent an Urgent-Medical Device Recall Notification dated April 7, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm first requested that customers notify their consignees of the recall and the risk, and risk mitigation factors. The firm requests that customers take the following field actions: -Upon receipt of the Field Safety Notice to review inventory to determine if affected screw --part number 71240-14, lot 685904 is in their possession. -If the product is in their possession to please abstain from use and contact Alphatec Spine Customer Service (customerservice@alphatecspine.com) immediately for instructions on how to return the affected product. All shipping instructions will be provided, including replace product and/or credit. -Fill out page 3 of the letter to confirm that they have read the notification and have take all necessary actions stated in the notification. -Return a signed copy using one of the methods below: Mail to: Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Fax to: 1-800 431-7729 For further questions call ( 760) 431-9286.

Device

4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm
  • Model / Serial
    Part Number: 71240-14 Lot: 685904
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia.
  • Product Description
    4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm || Alphatec Spine || Solutions for the Aging Spine || Trestle Luxe Anterior Cervical Plating System || REF 71240-14 || LOT XXXXXX || Alphatec Spine, Inc. || EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) || NON STERILE || Single Use Only
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Manufacturer Address
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • Manufacturer Parent Company (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA