Z-1020-2009

Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140...

Name: Z-1020-2009 Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140...
Creator: Theragenics Corporation
Published: 2008-12-08
License: https://open.fda.gov/license/

Theragenics Corp. / initiated 2008-12-08 / Terminated / root cause: packaging

FDA source

Theragenics Corporation began a recall of Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203... on 2008-12-08. The reason FDA records is "Some pouches were found to have weak seals potentially compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1020-2009
Status: Terminated
Initiated: 2008-12-08
Posted: 2009-03-31
Terminated: 2009-04-06
Recalling firm: Theragenics Corp.
Product: 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.
Product code: NQO Prosthesis, Spinous Process Spacer/Plate
Reason for recall: Some pouches were found to have weak seals potentially compromising sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 62 units
Distribution: Nationwide Distribution -- states of VA, WI, and CO.
Product codes and lots: 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 code NQO

K072296Class IIPoiint of Care Stranding System, Mode 1004-00Theragenics Corp. / cleared 2007-09-26

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)