Events

Recall of Device Recall Invue Split Driver, Assembly with Handle

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
    65444
  • Event Risk Class
    Class 2
  • Event Number
    Z-1927-2013
  • Event Initiated Date
    2013-05-10
  • Event Date Posted
    2013-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119841
  • 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
    Screwdriver - Product Code HXX
  • Reason
    Device design.
  • Action
    SpineFrontier sent an URGENT Advisory Notice dated June 27, 2013, to all affected consignees regarding the use of Invue Drivers. The notice advises users that the Split Tip Stylet Driver Assembly (11-70099) and Sold Driver, AO Connection (11-70070 or 11-70077) are being shipped in place of the Split Driver Assembly w/Handle (SI70006). The uses of the replacement parts are explained. Consignees are instructed to complete the Acknowledgement Form and return it to SpineFrontier. On June 28, 2013, customers were sent a second Advisory Notice requesting the removal of the Split Driver Assy w/ Handle Part Number SI70006 Lot Numbers 027104 and 027105. Consignees were instructed to complete the Acknowledgement Form and return it to SpineFrontier. Consignees with questions were instructed to call 978-232-3990.

Device

Device Recall Invue Split Driver, Assembly with Handle
  • Model / Serial
    Lot/Serial Numbers: 027104, 027105
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Texas, Ohio, and Missouri.
  • Product Description
    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. || The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
  • 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