Events

Recall of Osteopore

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OSTEOPORE INTERNATIONAL PTE LTD.

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
    59231
  • Event Risk Class
    Class 2
  • Event Number
    Z-0446-2012
  • Event Initiated Date
    2011-04-27
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101903
  • 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
    bone filler - Product Code GXP
  • Reason
    Product sterility may be compromised.
  • Action
    Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.

Device

Osteopore
  • Model / Serial
    Serial number LP-07-000695-714, lot number P0009032007-NW-05, expiry date Jul-12; Serial number TT-07-002201-2500, lot number P0009032007-NW-05, expiry date Sep-12; and Serial number PL-09-000006 to 15, lot number P0010112007-NW-05, expiry date Dec-12.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution - one distributor in TX.
  • Product Description
    Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
  • Manufacturer
    OSTEOPORE INTERNATIONAL PTE LTD

Manufacturer

OSTEOPORE INTERNATIONAL PTE LTD
  • Manufacturer Address
    OSTEOPORE INTERNATIONAL PTE LTD, 10, SCIENCE PARK ROAD, THE ALPHA, #02-28, SINGAPORE Singapore
  • Manufacturer Parent Company (2017)
    Osteopore International Pte. Ltd
  • Source
    USFDA