Recall Z-2690-2011 ยท KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
LINA Medical ApS
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.
| Date | Jun 28, 2011 (initiated Dec 1, 2009) |
| Status | Terminated |
| Reason | Potential for the LiNA Loop to break during operating procedure. |
| Root 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 | 1,950 pieces |
| Distribution | GA, MN, PA, WA, TN, MA, IN, Ontario Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 Lina Medical Aps, Oct 30, 2007 |