|
Class 3 Device Recall Mitek M. Kurosaka Advantage |
|
Date Initiated by Firm |
February 28, 2003 |
Date Posted |
April 01, 2003 |
Recall Status1 |
Terminated 3 on February 04, 2004 |
Recall Number |
Z-0697-03 |
Recall Event ID |
25698 |
510(K)Number |
K933738
|
Product Classification |
Screw, Fixation, Bone - Product Code HWC
|
Product |
Mitek M. Kurosaka Advantage 9 X 30 mm Cannulated Fixation Screw Product Reference No.: 230120 |
Code Information |
Lot Number: 0301591 |
Recalling Firm/ Manufacturer |
Mitek Worldwide 249 Vanderbilt Drive Norwood MA 02062
|
For Additional Information Contact |
James Kenney 781-251-3102
|
Manufacturer Reason for Recall |
Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm
|
FDA Determined Cause 2 |
Other |
Action |
Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03. |
Quantity in Commerce |
29 |
Distribution |
CO, FL, MN, PA, TX
International- Mitek Affiliates: Australia, Columbia, Japan UK, |
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 = DEPUY, INC.
|
|
|
|