Events

Recall of Device Recall MEDPOR Surgical Implant, Catalog 6317, 20mm Sphere

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Porex Surgical, 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
    31604
  • Event Risk Class
    Class 3
  • Event Number
    Z-0712-05
  • Event Initiated Date
    2005-03-07
  • Event Date Posted
    2005-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38226
  • 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
    Implant, Eye Sphere - Product Code HPZ
  • Reason
    The product, which is a 20mm medpor sphere, was mislabeled in that the package contained 18mm medpor spheres.
  • Action
    On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent.

Device

Device Recall MEDPOR Surgical Implant, Catalog 6317, 20mm Sphere
  • Model / Serial
    Lot A004A02
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AZ, IL, NJ and Korea
  • Product Description
    MEDPOR¿ Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA
  • Manufacturer
    Porex Surgical, Inc.

Manufacturer

Porex Surgical, Inc.
  • Manufacturer Address
    Porex Surgical, Inc., 15 Dart Rd, Newnan GA 30265-1017
  • Source
    USFDA