Events

Recall of Device Recall Single Use PERPOS PLS System

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
    60096
  • Event Risk Class
    Class 2
  • Event Number
    Z-0420-2012
  • Event Initiated Date
    2008-02-22
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104417
  • 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
    Bit, drill - Product Code HTW
  • Reason
    The recall was intiated because interventional spine has confirmed that the perpos 2-in-1 drill (6070) manufactured by a contract manufacturer for interventional spine, inc., may break during use.
  • Action
    The recall communication was initiated on February 22, 2008 with Interventional Spine forwarding an Urgent Recall Notification to all their customers (via email). The notification informed the customers of the problem identified and instructions for the recall. If you have any questions, contact the Vice President, Quality, Regulatory and Clinical Affairs at (949) 525-1493 or email: jmetcalf@i-spineinc.com.

Device

Device Recall Single Use PERPOS PLS System
  • Model / Serial
    Lot#090907A
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, FL, MO, NY, OH, PA, TN, WA, and WI; and country of: Europe.
  • Product Description
    Single Use PERPOS PLS System, Catalog #9045-01 || Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERPOS 2-in-1 Drill, PERPOS Tap, PERPOS Device Driver, 4.5mm BONE-LOK PLS Implant, and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through immobilization of the facet joints.
  • 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