FDA Medical Device Recalls (openFDA)
Worldwide Medical Technologies, LLC: 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
- Recall number
- Z-0040-2012
- 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
- Status
- Terminated
- Initiated
- 2011-08-12
- Posted
- 2011-10-12
- Terminated
- 2012-09-19
- Reason
- Length of the cannula hub is longer and may not permit a fit with the Applicator
- 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
- 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.
- Lot, serial or model codes
- Product code PSS1820AT Lot 116261, Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWJ
- Firm FEI
- 3000206637
- Firm city
- Oxford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28