Morcellex tissue morcellator and Morecellex Sigma generator (2014-04-28)

Starting date:

April 28, 2014

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-39481

• Reason
• Affected products

Recalled products

1. Morcellex tissue Morcellator
2. X-tract Morcellator
3. Morcellex Sigma - Generator
4. Morcellex Sigma -   Handpiece

Reason

Customers are being made aware that the US-FDA issued a safety communication on April 17, 2014, discouraging the use of laparoscopic uterine power morcellation in hysterectomy or myomectomy in women with uterine fibroids, because of the risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider alternative treatment options for symptomatic uterine fibroids.

Affected products