Events

Recall of Device Recall APLIF Implants and Instruments

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spinal Solutions, LLC.

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
    64578
  • Event Risk Class
    Class 2
  • Event Number
    Z-1157-2013
  • Event Initiated Date
    2013-03-08
  • Event Date Posted
    2013-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116518
  • 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
    Spinal solutions is recalling the aplif system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. these inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.
  • Action
    Spinal Solutions LLC sent an Urgent Medical Device Recall letter dated April 12, 2013, to all affected customers. The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to discontinue use of the affected product and return to the firm. Customers were also instructed to complete the bottom of the form and to return it by fax to (858) 764-9739. For questions regarding this recall call 951-304-9001.

Device

Device Recall APLIF Implants and Instruments
  • Model / Serial
    All lots are subject to this recall.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NV, WI, MD,and CA.
  • Product Description
    APLIF Implants and Instruments, || Part Numbers: || 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree || 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree || 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree || 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10degree || 184016-10 Anterior Psoas Lumbar 18 x 40 x 16mm - 10degree || 184008-00 Anterior Psoas Lumbar 18 x 40 x 08mm - 00degree || 184010-00 Anterior Psoas Lumbar 18 x 40 x 10mm - 00degree || 184012-00 Anterior Psoas Lumbar 18 x 40 x 12mm - 00degree || 184014-00 Anterior Psoas Lumbar 18 x 40 x 14mm - 00degree || 184016-00 Anterior Psoas Lumbar 18 x 40 x 16mm - 00degree || 184510-08 Anterior Psoas Lumbar 18 x 45 x 08mm - 10degree || 184510-10 Anterior Psoas Lumbar 18 x 45 x 10mm - 10degree || 184512-10 Anterior Psoas Lumbar 18 x 45 x 12mm - 10degree || 184514-10 Anterior Psoas Lumbar 18 x 45 x 14mm - 10degree || 184516-10 Anterior Psoas Lumbar 18 x 45 x 16mm - 10degree || 184510-00 Anterior Psoas Lumbar 18 x 45 x 10mm - 00degree || 184512-00 Anterior Psoas Lumbar 18 x 45 x 12mm - 00degree || 184514-00 Anterior Psoas Lumbar 18 x 45 x 14mm - 00degree || 184516-00 Anterior Psoas Lumbar 18 x 45 x 16mm - 00degree || 185008-10 Anterior Psoas Lumbar 18 x 50 x 08mm - 10degree || 185010-10 Anterior Psoas Lumbar 18 x 50 x 10mm - 10degree || 185012-10 Anterior Psoas Lumbar 18 x 50 x 12mm - 10degree || 185014-10 Anterior Psoas Lumbar 18 x 50 x 14mm - 10degree || 185016-10 Anterior Psoas Lumbar 18 x 50 x 16mm - 10degree || 185008-00 Anterior Psoas Lumbar 18 x 50 x 08mm - 00degree || 185010-00 Anterior Psoas Lumbar 18 x 50 x 10mm - 00degree || 185012-00 Anterior Psoas Lumbar 18 x 50 x 12mm - 00degree || 185014-00 Anterior Psoas Lumbar 18 x 50 x 14mm - 00degree || 185016-00 Anterior Psoas Lumbar 18 x 50 x 16mm - 00degree || 185508-10 Anterior Psoas Lumbar 18 x 55 x 08mm - 10degree || 185510-10 Anterior Psoas Lumbar 18 x 55 x 10mm - 10degree || 185512-10 Anterior Psoas Lumbar 18 x 55 x 12mm - 10degree || 185514-10 Anterior Psoas Lumbar 18 x 55 x 14mm - 10degree || 185516-10 Anterior Psoas Lumbar 18 x 55 x 16mm - 10degree || 185508-00 Anterior Psoas Lumbar 18 x 55 x 08mm - 00degree || 185510-00 Anterior Psoas Lumbar 18 x 55 x 10mm - 00degree || 185512-00 Anterior Psoas Lumbar 18 x 55 x 12mm - 00degree || 185514-00 Anterior Psoas Lumbar 18 x 55 x 14mm - 00degree || 185516-00 Anterior Psoas Lumbar 18 x 55 x 16mm - 00degree || The Eminent Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment.
  • Manufacturer
    Spinal Solutions, LLC

Manufacturer

Spinal Solutions, LLC
  • Manufacturer Address
    Spinal Solutions, LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA