Class 2 Device Recall LiNA Loop

• Date Initiated by Firm: December 01, 2009
• Date Posted: June 28, 2011
• Recall Status: Terminated on February 23, 2012
• Recall Number: Z-2690-2011
• 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, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Division.
• Code Information: Batch 9435, 9422, 9404, 9462, 9451, 9452, 9442, 9371, 9343, 9131, 9471, 7282, 8284, 8285, 8411, 8395, and 8442
• 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: 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: 1,950 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