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.
FDA Recall Z-2690-2011 · Posted 2011-06-28
Recalling FirmLINA Medical ApS
Recall StatusTerminated
Product CodeKNF
Date Initiated2009-12-01
Date Terminated2012-02-23
Product Quantity1,950 pieces
Reason for Recall
Potential for the LiNA Loop to break during operating procedure.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
GA, MN, PA, WA, TN, MA, IN, Ontario Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.