Events

Recall of Device Recall 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
    58465
  • Event Risk Class
    Class 2
  • Event Number
    Z-2719-2011
  • Event Initiated Date
    2011-03-23
  • Event Date Posted
    2011-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99408
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Reason
    This recall has been initiated due to k-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. removing the k-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw.
  • Action
    Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once. Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance. For further questions, please call (949) 472-0006

Device

Device Recall PERPOS PLS SYSTEM
  • Model / Serial
    LOT #'s: 040209-B, 041309-B
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of to NC, NY, TN & VA
  • Product Description
    PERPOS PLS SYSTEM, CATALOG NO. 9045-02 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.
  • 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