Events

Recall of TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Interpore Cross International 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
    25628
  • Event Risk Class
    Class 2
  • Event Number
    Z-0659-03
  • Event Initiated Date
    2003-02-07
  • Event Date Posted
    2003-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26174
  • 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 Manual Surgical Instrument - Product Code LXH
  • Reason
    Instrument fell apart during cleaning prior to surgery.
  • Action
    Firm telephoned customers on 2/7/2003 requesting that they immediately return thier instruments.

Device

TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.
  • Model / Serial
    Lot 32688
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    States of NJ, CA, PA, MN, WI, MO, FL, OH, VA, MD, Wash DC, NY, CO, MA and to Brazil, Mexico, England, Denmark, Belgium, Australia.
  • Product Description
    TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.
  • Manufacturer
    Interpore Cross International Inc

Manufacturer

Interpore Cross International Inc
  • Manufacturer Address
    Interpore Cross International Inc, 181 Technology Drive, Irvine CA 92618
  • Source
    USFDA