Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876
FDA Recall Z-0173-2010 · Posted 2009-11-10
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Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeHET
Date Initiated2009-09-28
Date Terminated2010-08-02
Product Quantity60,930 in US.
Reason for Recall
There is the potential for the duckbill seal to become dislodged.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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, New Zealand, Puerto Rico, Reunion, Russian Federation, Sweden, Slovina, Turkey, Saudi Arabia, Venezuela and S. Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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