|
Class 2 Device Recall TIGER Canulated Screw System |
|
Date Initiated by Firm |
April 14, 2009 |
Date Posted |
April 26, 2010 |
Recall Status1 |
Terminated 3 on May 03, 2010 |
Recall Number |
Z-1438-2010 |
Recall Event ID |
55180 |
510(K)Number |
K081510
|
Product Classification |
screw, fixation, bone - Product Code HWC
|
Product |
2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 |
Code Information |
Lot #0924081 |
Recalling Firm/ Manufacturer |
Trilliant Surgical LTD 448 W 19th St Ste 366 Houston TX 77008-3914
|
For Additional Information Contact |
800-495-2919
|
Manufacturer Reason for Recall |
Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.
|
FDA Determined Cause 2 |
Other |
Action |
Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919. |
Quantity in Commerce |
32 units |
Distribution |
WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD |
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 = HWC and Original Applicant = TRILLIANT SURGICAL LTD
|
|
|
|