Karl Strorz Morcellators ( 2015-05-13)

Starting date:

May 13, 2015

Posting date:

June 10, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53721

• Reason
• Affected products

Recalled Products

A. SAWALHE Morcellator
B. RotoCut Morcellator

Reason

When a laparoscopic power morcellator is used on a patient with (undiagnosed) cancer, there is a possibility that the cancer may be upstaged, and therefore, shorten the patient's life span. Health Canada posted a safety information notice to hospitals on May 7, 2014 regarding the use of the device and risk of spreading unsuspected uterine sarcoma. Health Canada requested a labelling change under section 39 of the medical devices on December 8, 2014 and posted an updated communication on their website on December 10, 2014. Karl Storz is revising their user manuals in compliance with Health Canada's recommendations.

Affected products