Recall Z-1020-2009 ยท NQO Prosthesis, Spinous Process Spacer/Plate
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.
| Date | Mar 31, 2009 (initiated Dec 8, 2008) |
| Status | Terminated |
| Reason | Some pouches were found to have weak seals potentially compromising sterility. |
| 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 | 62 units |
| Distribution | Nationwide Distribution -- states of VA, WI, and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 Theragenics Corp., Sep 26, 2007 |