Events

Recall of Novel VBR Spinal 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
    48177
  • Event Risk Class
    Class 2
  • Event Number
    Z-0508-2009
  • Event Initiated Date
    2007-08-16
  • Event Date Posted
    2008-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74679
  • 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
    Spinal Vertebral Body Replacement Device - Product Code MQP
  • Reason
    Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. they were incorrectly laser marked with the wrong part numbers and sizes. two lots were mixed from the following lot numbers: part number 64733-120 lot number 611884, and part number 64753-126 and lot number 611881.
  • Action
    The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.

Device

Novel VBR Spinal System
  • Model / Serial
    Lot Number: 611881
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of AZ, FL, NY & TX.
  • Product Description
    Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. || Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Manufacturer Address
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • Manufacturer Parent Company (2017)
    Alphatec Spine Inc
  • Source
    USFDA