Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
FDA device recall Z-0476-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- QLT USA, Inc.
- Reason for recall
- Injectable needles were included in procedure kits instead of sterile blunt cannulas.
- Action taken
- Consignee was notified by letter on 1/26/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYC
- Quantity affected
- 136 / 3 pack units
- Distribution
- PA
- Date initiated
- 2006-01-26
- Date posted
- 2006-02-04
- Date terminated
- 2006-04-27
- Location
- Fort Collins, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT (K982865) | Atrix Laboratories, Inc. | 1998-09-08 |