Z-2689-2011

LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm...

Name: Z-2689-2011 LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm...
Creator: LINA Medical ApS
Published: 2009-12-01
License: https://open.fda.gov/license/

LiNA Medical Inc / initiated 2009-12-01 / Terminated / root cause: labeling and UDI

FDA source

LINA Medical ApS began a recall of 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... on 2009-12-01. The reason FDA records is "Potential for the LiNA Loop to break during operating procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2689-2011
Status: Terminated
Initiated: 2009-12-01
Posted: 2011-06-28
Terminated: 2012-02-23
Recalling firm: LiNA Medical Inc
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.
Product code: KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Reason for recall: Potential for the LiNA Loop to break during operating procedure.
Root cause tag: labeling and UDI
FDA 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 in commerce: 570 pieces
Distribution: GA, MN, PA, WA, TN, MA, IN, Ontario Canada
Product codes and lots: Batch 9375, 9395, 9323, 8292, 8393, and 9231

Product code KNF

K070315Class IILina Loop, Models: El-160-4, El-160-8, El-200-4, El-200-8Lina Medical Aps / cleared 2007-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)