Events

Recall of Vu aPOD Intervertebral Body Fusion Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    57100
  • Event Risk Class
    Class 2
  • Event Number
    Z-1475-2011
  • Event Initiated Date
    2010-10-19
  • Event Date Posted
    2011-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95392
  • 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
    The ifu provided with the device contains incorrect information in the indications for use section, stating the following: the theken spine vu a"pod intervertebral body fusion device is intended for use as a stand alone implant when used with the spinplate provided in the set.
  • Action
    On 10/19/2010 the firm sent "URGENT : FIELD CORRECTION ACTION Letters to their customers. The letters identified the affected product and explained the reason for the recall. The letter also stated that the issue is not believed to have a health impact on patients. Physicians are asked to continue to exercise their clinical judgment with any periodic patient follow up. Attached to the letters were IFUs containing the correct information. Customers are to complete and return the enclosed Recall Acknowledgement Form per the instructions provided. Questions can be directed to Suzanne B. Wojcik, Sr. Dir Regulatory Affairs and Quality Assurance, at 330-835-8528.

Device

Vu aPOD Intervertebral Body Fusion Device
  • Model / Serial
    Model #'s: 21-11-2708, 21-21-2710, 21-23-3510, 21-40-0110, 21-LT-3508, 21-11-2710, 21-21-2712, 21-23-3512, 21-40-0120, 21-LT-3510, 21-11-2712, 21-21-2714, 21-23-3514, 21-40-0130, 21-LT-3512, 21-11-3108, 21-21-2716, 21-23-3516, 21-40-0131, 21-LT-3514, 21-11-3110, 21-21-3108, 21-23-3908, 21-40-0135, 21-LT-3516, 21-11-3112, 21-21-3110, 21-23-3910, 21-40-0140, 21-LT-3908, 21-11-3114, 21-21-3112, 21-23-3912, 21-40-0150, 21-LT-3910, 21-11-3116, 21-21-3114, 21-23-3914, 21-40-0160, 21-LT-3912, 21-11-3508, 21-21-3116, 21-23-3916, 21-40-0165, 21-LT-3914, 21-11-3510, 21-21-3508, 21-24-2708, 21-40-0170, 21-LT-3916, 21-11-3512, 21-21-3510, 21-24-2710, 21-40-0180, 21-TA-2708, 21-11-3514, 21-21-3512, 21-24-2712, 21-40-0190, 21-TA-2710, 21-11-3516, 21-21-3514, 21-24-2714, 21-40-0190-3, 21-TA-2712, 21-11-3908, 21-21-3516, 21-24-2716, 21-40-0200, 21-TA-2714, 21-11-3910, 21-21-3908, 21-24-3108, 21-40-0215, 21-TA-2716, 21-11-3912, 21-21-3910, 21-24-3110, 21-40-0245, 21-TA-3108, 21-11-3914, 21-21-3912, 21-24-3112, 21-40-0290, 21-TA-3110, 21-11-3916, 21-21-3914, 21-24-3114, 21-40-0400, 21-TA-3112, 21-20-2708, 21-21-3916, 21-24-3116, 21-40-0500, 21-TA-3114, 21-20-2710, 21-22-3112, 21-24-3508, 21-50-0100, 21-TA-3116, 21-20-2712, 21-22-3114, 21-24-3510, 21-50-0110, 21-TA-3508, 21-20-2714, 21-22-3116, 21-24-3512, 21-50-0210, 21-TA-3510, 21-20-2716, 21-22-3512, 21-24-3514, 21-50-0310, 21-TA-3512, 21-20-3108, 21-22-3514, 21-24-3516, 21-50-0410, 21-TA-3514, 21-20-3110, 21-22-3516, 21-24-3908, 21-99-0001, 21-TA-3516, 21-20-3112, 21-22-3912, 21-24-3910, 21-99-0002, 21-TA-3908, 21-20-3114, 21-22-3914, 21-24-3912, 21-99-0002-2-1, 21-TA-3910, 21-20-3116, 21-22-3916, 21-24-3914, 21-99-0002-3-1, 21-TA-3912, 21-20-3508, 21-23-2708, 21-24-3916, 21-99-0002-3-2, 21-TA-3914, 21-20-3510, 21-23-2710, 21-25-3112, 21-LT-2708, 21-TA-3916, 21-20-3512, 21-23-2712, 21-25-3114, 21-LT-2710, 21-XT-3112, 21-20-3514, 21-23-2714, 21-25-3116, 21-LT-2712, 21-XT-3114, 21-20-3516, 21-23-2716, 21-25-3512, 21-LT-2714, 21-XT-3116, 21-20-3908, 21-23-3108, 21-25-3514, 21-LT-2716, 21-XT-3512, 21-20-3910, 21-23-3110, 21-25-3516, 21-LT-3108, 21-XT-3514, 21-20-3912, 21-23-3112, 21-25-3912, 21-LT-3110, 21-XT-3516, 21-20-3914, 21-23-3114, 21-25-3914, 21-LT-3112, 21-XT-3912, 21-20-3916, 21-23-3116, 21-25-3916, 21-LT-3114, 21-XT-3914, 21-21-2708, 21-23-3508, 21-40-0100, 21-LT-3116 & 21-XT-3916.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.
  • Product Description
    Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Theken Spine, LLC, Akron, OH 44306. || Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.