Events

Recall of Device Recall SpineFrontier

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
    70488
  • Event Risk Class
    Class 2
  • Event Number
    Z-1479-2015
  • Event Initiated Date
    2015-03-05
  • Event Date Posted
    2015-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133889
  • 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
    Tape, measuring, rulers and calipers - Product Code FTY
  • Reason
    The pedfuse pedicle screw rod caliper included with the misquito pedicle screw system may be used incorrectly as the surgical technique does not adequately convey the intended use of the design.
  • Action
    SpineFrontier sent an Urgent Advisory Notice letter to customers via email. The letter identified the affected product, problem and actions to be taken. Customers were asked complete and return the Acknowledgement Form to confirm receipt of the recall notification. For questions call 978-232-3990.

Device

Device Recall SpineFrontier
  • Model / Serial
    Revision E
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of TX, KS, CO, and MA
  • Product Description
    SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
  • 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