Events

Recall of Solanas

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
    53144
  • Event Risk Class
    Class 2
  • Event Number
    Z-0503-2010
  • Event Initiated Date
    2009-08-05
  • Event Date Posted
    2009-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84770
  • 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
    Pedicle Screw - Product Code KWP
  • Reason
    Alphatec spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
  • Action
    Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.

Device

Solanas
  • Model / Serial
    Lot Numbers: 624241, 624242, 625418
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution.
  • Product Description
    Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
  • 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