Events

Recall of Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System

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
    65165
  • Event Risk Class
    Class 2
  • Event Number
    Z-1421-2013
  • Event Initiated Date
    2013-05-06
  • Event Date Posted
    2013-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118068
  • 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, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    Alphatec spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the phygen leucadia" autolok set screw may interfere with the top of the screw head prior to fully locking the rod. if this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. to date there have been no reports of patient injury, adve.
  • Action
    Alphatec Spine initiated recall by contacting customers via telephone and/or email on 05/06/2013. An Urgent Medical Device Recall Notification letter along with a response form were sent via FedEx to all affected accounts. The letter identified the product, problem, and actions to be taken by the customers.

Device

Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System
  • Model / Serial
    83010 85001 85002 83005-30  83005-35  83005-40  83005-45  83005-50  83006-30  83006-35  83006-40  83006-45  83006-50  83006-55  83006-60  83007-30  83007-35  83007-40  83007-45  83007-50  83007-55  83008-30  83008-35  83008-40  83008-45  83008-50  83008-55  83008-80  82001-1    Catalog Numbers: LA-HSS0010  LA-HDOO01  LA-CTOO02  LA-PS0530  LA-PS0535  LA-PS0540  LA-PS0545  LA-PS0550  LA-PS0630  LA-PS0635  LA-PS0640  LA-PS0645  LA-PS0650  LA-PS0655  LA-PS0660  LA-PS0730  LA-PS0735  LA-PS0740  LA-PS0745  LA-PS0750  LA-PS0755  LA-PS0830  LA-PS0835  LA-PS0840  LA-PS0845  LA-PS0850  LA-PS0855  LA-PS0880  LA-SOO01   Lots Affected: All
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Leucadia Autolok" Polyaxial Pedicle Screw System. || Intended to help provide correction, immobilization and stabilization of spinal segments.
  • 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