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U.S. Department of Health and Human Services

Class 2 Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5).

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  Class 2 Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5). see related information
Date Initiated by Firm December 08, 2008
Date Posted March 31, 2009
Recall Status1 Terminated 3 on April 06, 2009
Recall Number Z-1020-2009
Recall Event ID 51177
510(K)Number K072296  
Product Classification Source, brachytherapy, radionuclide - Product Code NQO
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Theragenics Corporation
5203 Bristol Industrial Way
Buford GA 30518
For Additional Information Contact Betsy Cortelloni
770-271-0233 Ext. 4294
Manufacturer Reason
for Recall		 Some pouches were found to have weak seals potentially compromising sterility.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NQO and Original Applicant = THERAGENICS CORP.
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