Events

Recall of Prostate Seeding Needle, Applicator Technique

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Worldwide Medical Technologies, LLC.

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
    59712
  • Event Risk Class
    Class 2
  • Event Number
    Z-0040-2012
  • Event Initiated Date
    2011-08-12
  • Event Date Posted
    2011-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103394
  • 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
    Manual Radionuclide Applicator System - Product Code IWJ
  • Reason
    Length of the cannula hub is longer and may not permit a fit with the applicator.
  • Action
    BrachySciences, a division of Biocompatibles, Inc., sent out "Urgent Recall Device Recall" letters Dated August 12, 2011 to all affected customers. The letter included affected product and problem description. Customers are asked to quarantine and return unused product. A Product Recall & Retrieval Form was included to send back to the firm. For questions on this recall contact the firm at (203) 262-0571, extension 105.

Device

Prostate Seeding Needle, Applicator Technique
  • Model / Serial
    Product code PSS1820AT Lot 116261, Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution including the states of AR, CO, DE. FL, KY, MD, MI, MN, NY, TX, and VA; and the countries of Belgium, and Germany.
  • Product Description
    Prostrate Seeding Applicator Needle. Product code PSS1820AT || Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. || Worldwide Medical Technologies, LLC || Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate
  • Manufacturer
    Worldwide Medical Technologies, LLC

Manufacturer

Worldwide Medical Technologies, LLC
  • Manufacturer Address
    Worldwide Medical Technologies, LLC, 115 Hurley Rd Ste 3b, Oxford CT 06478-1047
  • Manufacturer Parent Company (2017)
    Worldwide Medical Technologies Llc
  • Source
    USFDA