Events

Recall of Device Recall Novel Spinal Spacer 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
    52759
  • Event Risk Class
    Class 2
  • Event Number
    Z-0190-2010
  • Event Initiated Date
    2009-05-13
  • Event Date Posted
    2009-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83897
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    Due to a deficiency in the process validation related to the machine that manufactured these parts, alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
  • Action
    Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.

Device

Device Recall Novel Spinal Spacer System
  • Model / Serial
    Part Number(s): 64817-010 Lot Number(s): 623549; Part Number(s): 64817-012 Lot Number(s): 623551; Part Number(s): 64817-013 Lot Number(s): 623552; Part Number(s): 64817-014 Lot Number(s): 623553; Part Number(s): 64817-107 Lot Number(s): 623584; Part Number(s): 64113-012 Lot Number(s): 623619; Part Number(s): 64113-010 Lot Number(s): 623620; Part Number(s): 64765-109 Lot Number(s): 623909; and Part Number(s): 64733-124 Lot Number(s): 623778.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
  • Product Description
    Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. || Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
  • 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