Events

Recall of Device Recall SLift Implant Guides

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SpineFrontier, 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
    63075
  • Event Risk Class
    Class 2
  • Event Number
    Z-0417-2013
  • Event Initiated Date
    2012-08-22
  • Event Date Posted
    2012-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112475
  • 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
    When using the optional s-lift (also known as s-lif) implant guides without stops, there is a known risk of moving the implant guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. the instructions for use for the s-lift implant guides will be amended to add the following warning: "care is to be taken to not over insert the implant guides.
  • Action
    Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.

Device

Device Recall SLift Implant Guides
  • Model / Serial
    Lot Numbers: 012064-001
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide including the states of: MA and TX.
  • Product Description
    S-Lift Implant Guides (also known as S-LIF) || Compressor Part Number: 11-50223 || Product Usage: || Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • Manufacturer Address
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Manufacturer Parent Company (2017)
    SpineFrontier, Inc.
  • Source
    USFDA