Date Initiated by Firm |
February 08, 2007 |
Date Posted |
June 27, 2007 |
Recall Status1 |
Terminated 3 on February 24, 2008 |
Recall Number |
Z-0968-2007 |
Recall Event ID |
37300 |
510(K)Number |
K031623
|
Product Classification |
Anastomotic Device Removal Tool - Product Code FZP
|
Product |
Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices. |
Code Information |
lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204 |
Recalling Firm/ Manufacturer |
Medtronic Cardiac Surgery Technologies 7601 Northland Dr N Minneapolis MN 55428-1088
|
Manufacturer Reason for Recall |
Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.
|
FDA Determined Cause 2 |
Other |
Action |
Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information. |
Quantity in Commerce |
187 (US 155, OUS 32) |
Distribution |
Nationwide and Canada. |
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 = FZP and Original Applicant = COALESCENT SURGICAL
|