Recall Z-0173-2010 ยท HET Laparoscope, Gynecologic (And Accessories)
Ethicon, Inc.
Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876
| Date | Nov 10, 2009 (initiated Sep 28, 2009) |
| Status | Terminated |
| Reason | There is the potential for the duckbill seal to become dislodged. |
| Root cause | Device Design |
| Action | Recall notification letters titled "URGENT VOLUNTARY PRODUCT RECALL" were sent on 10/8/2009 via UPS next day. The letters describe the lots within expiration that are recalled. The motor drive unit is not included in the recall. Letters have photos and illustrations of the product which clearly show the location of the product code and expiration date. Recalled product is to be returned to Stericyle using an enclosed pre-paid authorized shipping label. Ethicon will notify customers when the product is available. Questions are to be directed to Ethicon at 1-888-276-5901. |
| Quantity | 60,930 in US. |
| Distribution | Worldwide distribution - US and United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Greece, Israel, Italy, Jordan, Republic of Korea, Mexico, Malaysia, Netherlands, Norway, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061050 | GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R ETHICON, Inc., Jul 14, 2006 |