Date Initiated by Firm |
January 26, 2006 |
Date Posted |
February 04, 2006 |
Recall Status1 |
Terminated 3 on April 27, 2006 |
Recall Number |
Z-0476-06 |
Recall Event ID |
34506 |
510(K)Number |
K982865
|
Product Classification |
Bone Grafting Material, Synthetic - Product Code LYC
|
Product |
Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile |
Code Information |
Lot 2072A, Exp 5/2007 |
Recalling Firm/ Manufacturer |
QLT USA, Inc. 701 Centre Avenue Fort Collins CO 80526-1843
|
For Additional Information Contact |
970-482-5868
|
Manufacturer Reason for Recall |
Injectable needles were included in procedure kits instead of sterile blunt cannulas.
|
FDA Determined Cause 2 |
Other |
Action |
Consignee was notified by letter on 1/26/2006. |
Quantity in Commerce |
136 / 3 pack units |
Distribution |
PA |
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 = LYC and Original Applicant = ATRIX LABORATORIES, INC.
|