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Terminated

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.

FDA Recall Z-2689-2011 · Posted 2011-06-28

Recalling FirmLINA Medical ApS
Recall StatusTerminated
Product CodeKNF
Date Initiated2009-12-01
Date Terminated2012-02-23
Product Quantity570 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.

K070315LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007-10-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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