Theragenics Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Theragenics Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Theragenics Corporation is recalling Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3 due to Some pouches were found to have weak seals potentially compromising sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some pouches were found to have weak seals potentially compromising sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026