Events

Recall of Device Recall PERPOS Driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Interventional Spine 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
    58461
  • Event Risk Class
    Class 2
  • Event Number
    Z-0047-2012
  • Event Initiated Date
    2011-02-03
  • Event Date Posted
    2011-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99403
  • 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
    Orthopedic Screwdriver - Product Code HXX
  • Reason
    This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. use of this product may result in a delay of the surgical procedure.
  • Action
    Interventional Spine, Inc. sent an "Urgent Recall" letter dated March 15, 2011 to all affected customers. The letter included; affected product, reason for recall and recommendations. Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain. For information on this recall contact the firm at (949) 472-0006.

Device

Device Recall PERPOS Driver
  • Model / Serial
    DRIVER CATALOG NO. 6112; 050507A, 061509A, 071808A, 112507A, 042709E
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.
  • Product Description
    PERPOS Driver; Catalog # 6112 || Interventional Spine, Inc. || A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.
  • Manufacturer
    Interventional Spine Inc

Manufacturer

Interventional Spine Inc
  • Manufacturer Address
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Manufacturer Parent Company (2017)
    Interventional Spine Inc.
  • Source
    USFDA