|
Class 3 Device Recall Smith & Nephew |
|
Date Initiated by Firm |
April 06, 2005 |
Date Posted |
July 07, 2005 |
Recall Status1 |
Terminated 3 on June 07, 2006 |
Recall Number |
Z-0973-05 |
Recall Event ID |
32160 |
Product Classification |
Clamp, Surgical, General & Plastic Surgery - Product Code GDJ
|
Product |
Smith & Nephew Grasper, Cupped 3.4mm REF: 011014 |
Code Information |
Lot Number: 50088937 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc., Endoscopy Div. 130 Forbes Blvd Mansfield MA 02048-1145
|
For Additional Information Contact |
Jason Bilobram 978-474-6332
|
Manufacturer Reason for Recall |
Cupped Grasper Handle marked incorrectly as Duckbill Upbiter
|
FDA Determined Cause 2 |
Other |
Action |
Smith & Nephew Endoscopy notified users by letter dated 4/6/05. Accounts are requested to return product. |
Quantity in Commerce |
12 |
Distribution |
CA, OH, MA, TX |
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.
|
|
|
|