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Class 2 Device Recall LiNA Loop |
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Date Initiated by Firm |
December 01, 2009 |
Date Posted |
June 28, 2011 |
Recall Status1 |
Terminated 3 on February 23, 2012 |
Recall Number |
Z-2689-2011 |
Recall Event ID |
58444 |
510(K)Number |
K070315
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Product Classification |
endoscopic electrocautery - Product Code KNF
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Product |
LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery Division. |
Code Information |
Batch 9375, 9395, 9323, 8292, 8393, and 9231 |
Recalling Firm/ Manufacturer |
LINA Medical ApS Formervangen 5 Glostrup Denmark
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Manufacturer Reason for Recall |
Potential for the LiNA Loop to break during operating procedure.
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FDA Determined Cause 2 |
Labeling design |
Action |
Lina Medical Aps notified customers by newsletter in December 2009 followed by a letter to distributors including warnings added to instructions for use in January 2010. |
Quantity in Commerce |
570 pieces |
Distribution |
GA, MN, PA, WA, TN, MA, IN, Ontario Canada |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KNF and Original Applicant = LINA MEDICAL APS
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