Events

Recall of Device Recall BONELOK PLS Implant

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
    58381
  • Event Risk Class
    Class 2
  • Event Number
    Z-3034-2011
  • Event Initiated Date
    2011-03-15
  • Event Date Posted
    2011-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99410
  • 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
    System, facet screw spinal device - Product Code MRW
  • Reason
    This recall has been initiated due to pull pins that may disengage from the facet screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.
  • Action
    Interventional Spine, Inc. sent a recall letter dated March 15, 2011, informing consignees of the product, the problem, and the action to be taken. Consignees were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if they distributed the product further they were asked to notify Jane Metcalf, the Vice President of Quality Assurance at once. Interventional Spine further informed consignees that the recall was being carried out to the individual consignee level. And their assistance was appreciated and necessary to prevent use of this product. They were then asked to complete and return the enclosed response form as soon as possible. Questions were directed to call their regional directors. For questions regarding this recall call 949-472-0006.

Device

Device Recall BONELOK PLS Implant
  • Model / Serial
    CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A
  • Product Classification
    Orthopedic Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI
  • Product Description
    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant || A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.
  • 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