Events

Recall of Alpha Mirage Top Tightening Spinal System || 5.5 mm x 45 mm Length Bone Screws

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alphatec Mfg 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
    26410
  • Event Risk Class
    Class 2
  • Event Number
    Z-0949-03
  • Event Initiated Date
    2002-05-30
  • Event Date Posted
    2003-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27633
  • 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
  • Reason
    Laser marking is wrong on bone screws, says 40 and is 45 mm long.
  • Action
    Customers were notified by fax in a letter dated May 19, 2003. All customers have been notified.

Device

Alpha Mirage Top Tightening Spinal System || 5.5 mm x 45 mm Length Bone Screws
  • Model / Serial
    Lot 251219G
  • Distribution
    To FL, MD, CA, TX, Greece and Japan
  • Product Description
    Alpha Mirage Top Tightening Spinal System || 5.5 mm x 45 mm Length Bone Screws
  • Manufacturer
    Alphatec Mfg Inc

Manufacturer

Alphatec Mfg Inc
  • Manufacturer Address
    Alphatec Mfg Inc, 6110 Corte Del Cedro, Carlsbad CA 92009
  • Source
    USFDA