Events

Recall of LINA GOLD LOOP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUPERIOR MEDICAL LIMITED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    82881
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This recall has been initiated because in december of 2009 lina medical issued an update to their "instructions for use" (ifu) to inform users that the loops should not be pre-tested on patients nor be used if de-shaped from their original rhomboid form. doing so can cause the loop to weaken break or cease functioning and can prolong the surgery of the patient.

Device

LINA GOLD LOOP
  • Model / Serial
    Model Catalog: EL-200-8 (Lot serial: 00-H557000); Model Catalog: EL-200-4 (Lot serial: 00-H557000); Model Catalog: EL-160-8 (Lot serial: 00-H557000); Model Catalog: EL-200-8 (Lot serial: 00-O932300); Model Catalog: EL-200-4 (Lot serial: 00-O932300); Model Catalog: EL-160-8 (Lot serial: 00-O932300); Model Catalog: EL-200-8 (Lot serial: 00-C908986); Model Catalog: EL-200-4 (Lot serial: 00-C908986); Model Catalog: EL-160-8 (Lot serial: 00-C908986); Model Catalog: EL-200-8 (Lot serial: 00-V131400); Model Catalog: EL-200-4 (Lot serial: 00-V131400); Model Catalog: EL-200-8 (Lot serial: 00-S123960); Model Catalog: EL-200-4 (Lot serial: 00-S123960); Model Catalog: EL-160-8 (Lot serial: 00-S123960); Model Catalog: EL-160-8 (Lot serial: 00-V131400); Model Catalog: EL-200-8 (Lot serial: 00-B142800); Model Catalog: EL-200-4 (Lot serial: 00-B142800); Model Catalog: EL-160-8 (Lot serial: 00-B142800); Model Catalog: EL-200-8 (Lot serial: 00-C167200); Model Catalog: EL-200-4 (Lot serial: 00-C167200); Model Catalog: EL-160-8
  • Product Description
    LINA LOOP ENDOSCOPIC MONOPOLAR LOOP
  • Manufacturer
    SUPERIOR MEDICAL LIMITED

Manufacturer

SUPERIOR MEDICAL LIMITED