Events

Recall of Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5).

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Theragenics Corporation.

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
    51177
  • Event Risk Class
    Class 2
  • Event Number
    Z-1020-2009
  • Event Initiated Date
    2008-12-08
  • Event Date Posted
    2009-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78910
  • 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
    Source, brachytherapy, radionuclide - Product Code NQO
  • Reason
    Some pouches were found to have weak seals potentially compromising sterility.
  • Action
    Consignees were notified first by telephone on December 8, 2008 and sent a follow up letter dated January 13, 2009. They were instructed to return any of the affected lots remaining in their inventory.

Device

Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5).
  • Model / Serial
    Lot Numbers: 081009-01, 081009-02, 081009-03, 081023-01, 081023-02, 081106-01, 081106-02, 081106-03, 081113-01, 081113-02, 081113-03, 081113-04, 081113-05, 081118-01 and 081118-02.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- states of VA, WI, and CO.
  • Product Description
    Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. || The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. || by the attending physician.
  • Manufacturer
    Theragenics Corporation

Manufacturer

Theragenics Corporation
  • Manufacturer Address
    Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518
  • Manufacturer Parent Company (2017)
    Juniper Holdings Inc.
  • Source
    USFDA