Z-0040-2012

Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs...

Name: Z-0040-2012 Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs...
Creator: Worldwide Medical Technologies, LLC
Published: 2011-08-12
License: https://open.fda.gov/license/

Worldwide Medical Technologies, LLC / initiated 2011-08-12 / Terminated / root cause: manufacturing process

FDA source

Worldwide Medical Technologies, LLC began a recall of 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... on 2011-08-12. The reason FDA records is "Length of the cannula hub is longer and may not permit a fit with the Applicator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0040-2012
Status: Terminated
Initiated: 2011-08-12
Posted: 2011-10-12
Terminated: 2012-09-19
Recalling firm: Worldwide Medical Technologies, LLC
Product: 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
Product code: IWJ System, Applicator, Radionuclide, Manual
Reason for recall: Length of the cannula hub is longer and may not permit a fit with the Applicator
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 1872 units
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 codes and lots: Product code PSS1820AT Lot 116261, Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07

Product code IWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)