Events

Recall of Device Recall SLIFT

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
    65432
  • Event Risk Class
    Class 2
  • Event Number
    Z-1664-2013
  • Event Initiated Date
    2013-05-17
  • Event Date Posted
    2013-07-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118893
  • 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
    Tray, surgical, instrument - Product Code FSM
  • Reason
    The s-lift instrument case contained a bracket with peeling nylon coating.
  • Action
    Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a modification has been implemented for the improved durability of S-LIFT Case Brackets and that SpineFrontier has initiated removal of these cases from the field. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.

Device

Device Recall SLIFT
  • Model / Serial
    Lot/Serial Numbers: 7201.007 and 7201.007-1
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
  • Product Description
    BASE, S-LIFT Instrument Case || Product Usage: || System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
  • 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