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U.S. Department of Health and Human Services

Class 2 Device Recall LiNA Loop

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  Class 2 Device Recall LiNA Loop see related information
Date Initiated by Firm December 01, 2009
Date Posted June 28, 2011
Recall Status1 Terminated 3 on February 23, 2012
Recall Number Z-2688-2011
Recall Event ID 58444
510(K)Number K070315  
Product Classification endoscopic electrocautery - Product Code KNF
Product LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.
Code Information Batch 7415, 8283, 8453, 9081
Recalling Firm/
Manufacturer		 LINA Medical ApS
Formervangen 5
Glostrup Denmark
Manufacturer Reason
for Recall		 Potential for the LiNA Loop to break during operating procedure.
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 200 pieces
Distribution GA, MN, PA, WA, TN, MA, IN, Ontario 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 = KNF and Original Applicant = LINA MEDICAL APS
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