Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG31
FDA device recall Z-1020-2009 · posted 2009-03-31 · Terminated
Recall details
- Recalling firm
- Theragenics Corporation
- Reason for recall
- Some pouches were found to have weak seals potentially compromising sterility.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NQO
- Quantity affected
- 62 units
- Distribution
- Nationwide Distribution -- states of VA, WI, and CO.
- Date initiated
- 2008-12-08
- Date posted
- 2009-03-31
- Date terminated
- 2009-04-06
- Location
- Buford, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 (K072296) | Theragenics Corp. | 2007-09-26 |