Recall Z-0476-06 ยท LYC Bone Grafting Material, Synthetic
QLT USA, Inc.
Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
| Date | Feb 4, 2006 (initiated Jan 26, 2006) |
| Status | Terminated |
| Reason | Injectable needles were included in procedure kits instead of sterile blunt cannulas. |
| Root cause | Other |
| Action | Consignee was notified by letter on 1/26/2006. |
| Quantity | 136 / 3 pack units |
| Distribution | PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982865 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT Atrix Laboratories, Inc., Sep 8, 1998 |