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Health product recall

LiNA Xcise Laparoscopic Morcellator (2015-05-08)

Starting date:
May 8, 2015
Posting date:
June 26, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Identification number:
RA-53922

Recalled Product

A.LiNA Xcise Laparoscopic Morcellator

Reason

Pursuant to the FDA and Health Canada recommendations LiNA Medical ApS has added additional warnings and contraindications to the instructions for use (IFU) for the LiNA Xcise Laparoscopic Morcellator.

Affected products

A.LiNA Xcise Laparoscopic Morcellator

Lot or serial number

All Lot Numbers

Model or catalog number

MOR-1515
MOR-1515-6

Companies
Manufacturer
Lina Medical APS
Formervangen 5 Glostrup,Denmark, 2600
Glostrup
DENMARK