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Morcellex Tissue and X-tract Morcellator, and Morcellex Sigma - Generator and Hand Piece (2014-07-31)
- Starting date:
- July 31, 2014
- Posting date:
- August 8, 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-40983
Recalled products
- Morcellex Tissue Morcellator
- X-tract Morcellator
- Morcellex Sigma - Generator
- Morcellex Sigma - Hand Piece
Reason
Ethicon is expanding the April 2014 global commercial suspension and initiating a worldwide voluntary market withdrawal of all Ethicon Morcellation devices, including generators and disposables that currently remain in the market. The risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.
Affected products
A. Morcellex Tissue Morcellator
Lot or serial number
All lots
Model or catalog number
- MX0100
- MX0100R
Companies
- Manufacturer
-
Ethicon Inc.
Rt. 22 West, P.O. Box 151
Somerville, N.J.
08876
New Jersey
UNITED STATES
B. X-tract Morcellator
Lot or serial number
All lots
Model or catalog number
- DV0015
- MD0100
- MD0120
Companies
- Manufacturer
-
Ethicon Inc.
Rt. 22 West, P.O. Box 151
Somerville, N.J.
08876
New Jersey
UNITED STATES
C. Morcellex Sigma - Generator
Lot or serial number
All lots
Model or catalog number
- MD0200
Companies
- Manufacturer
-
Ethicon Inc.
Rt. 22 West, P.O. Box 151
Somerville, N.J.
08876
New Jersey
UNITED STATES
D. Morcellex Sigma - Hand Piece
Lot or serial number
All lots
Model or catalog number
- MX0200
- MX0200R
Companies
- Manufacturer
-
Ethicon Inc.
Rt. 22 West, P.O. Box 151
Somerville, N.J.
08876
New Jersey
UNITED STATES