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U.S. Department of Health and Human Services

Class 2 Device Recall Gynecare Morcellex Tissue Morcellator

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  Class 2 Device Recall Gynecare Morcellex Tissue Morcellator see related information
Date Initiated by Firm September 28, 2009
Date Posted November 10, 2009
Recall Status1 Terminated 3 on August 02, 2010
Recall Number Z-0173-2010
Recall Event ID 53535
510(K)Number K061050  
Product Classification Gynecologic laparoscope and accessories - Product Code HET
Product Gynecare Morcellex Tissue Morcellator;
Manufactured by: Ethicon Women's Health & Urology;
A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876
Code Information Product Code: MX0100 Hand Piece - 5 pack; Lot numbers:  MT212363 10/1/2009 MT212369 10/1/2009 MT212372 10/1/2009 MT212378 10/1/2009 MT212385 10/1/2009 MT212392 10/31/2009 MT212403 10/1/2009 MT212422 10/1/2009 MT212427 10/1/2009 MT212432 10/1/2009 MT212446 10/31/2009 MT212450 10/1/2009 MT212463 10/1/2009 MT212475 11/1/2009 MT212485 11/1/2009 MT212493 11/1/2009 MT212497 11/1/2009 MT212501 11/1/2009 MT212509 11/1/2009 MT212518 11/1/2009 MT212527 11/1/2009 MT212539 11/1/2009 MT212553 12/1/2009 MT212577 12/1/2009 MT212585 12/31/2009 MT212591 12/31/2009 MT212602 12/31/2009 MT212610 12/1/2009 MT212616 12/1/2009 MT212621 12/1/2009 MT212627 12/31/2009 MT212633 12/31/2009 MT212637 12/31/2009 MT212655 1/31/2010 MT212661 1/31/2010 MT212666 1/31/2010 MT212673 1/31/2010 MT212680 1/31/2010 MT212702 1/31/2010 MT212708 1/31/2010 MT212712 1/31/2010 MT212718 1/31/2010 MT212723 1/31/2010 MT212732 2/1/2010 MT212745 2/1/2010 MT212758 2/1/2010 MT212762 2/1/2010 MT212772 2/1/2010 MT212776 2/28/2010 MT212787 2/28/2010 MT212797 2/1/2010 MT212815 2/1/2010 MT212818 2/1/2010 MT212829 2/1/2010 MT212841 3/1/2010 MT212850 3/1/2010 MT212857 3/1/2010 MT212871 3/31/2010 MT212895 3/1/2010 MT212901 3/31/2010 MT212912 3/31/2010 MT212920 3/31/2010 MT212924 3/31/2010 MT212931 3/1/2010 MT212938 3/31/2010 MT212942 3/1/2010 MT212956 4/30/2010 MT212969 4/30/2010 MT212976 4/30/2010 MT212982 4/20/2010 MT212987 4/30/2010 MT212994 4/30/2010 MT213004 4/30/2010 MT213011 4/30/2010 MT213018 4/30/2010 MT213024 4/30/2010 MT213038 4/30/2010 MT213044 4/1/2010 MT213059 5/1/2010 MT213064 5/31/2010 MT213073 5/31/2010 MT213076 5/30/2010 MT213082 5/31/2010 MT213090 5/1/2010 MT213096 5/30/2010 MT213103 5/31/2010 MT213111 5/31/2010 MT213117 5/1/2010 MT213122 5/30/2010 MT213126 5/31/2010 MT213140 6/30/2010 MT213143 6/30/2010 MT213155 6/30/2010 MT213165 6/30/2010 MT213169 6/30/2010 MT213173 6/30/2010 MT213180 6/30/2010 MT213191 6/30/2010 MT213195 6/30/2010 MT213198 6/30/2010 MT213203 6/30/2010 MT213209 6/30/2010 MT213215 6/30/2010 MT213219 6/30/2010 MT213228 7/31/2010 MT213244 7/31/2010 MT213250 7/31/2010 MT213256 7/31/2010 MT213259 7/31/2010 MT213264 7/31/2010 MT213271 7/31/2010 MT213275 7/31/2010 MT213278 7/31/2010 MT213281 7/31/2010 MT213287 7/31/2010 MT213290 7/31/2010 MT213299 7/31/2010 MT213302 7/31/2010 MT213308 7/31/2010 MT213329 7/31/2010 MT213346 7/31/2010 MT213354 8/31/2010 MT213357 8/31/2010 MT213360 8/31/2010 MT213365 8/31/2010 MT213368 8/31/2010 MT213375 8/31/2010 MT213380 8/31/2010 MT213386 8/31/2010 MT213391 8/30/2010 MT213394 8/31/2010 MT213398 8/31/2010 MT213404 8/31/2010 MT213412 8/31/2010 MT213419 8/31/2010 MT213425 8/31/2010 MT213432 8/31/2010 MT213441 9/11/2010 MT213446 9/11/2010 MT213451 9/11/2010 MT213456 9/30/2010 MT213464 9/30/2010 MT213477 9/30/2010 MT213481 9/30/2010  Product Code: MX0100R- single, lot numbers: MT212406 10/1/2009 MT212561 12/1/2009 MT212697 1/31/2010 MT212750 2/1/2010 MT212811 2/1/2010 MT212868 3/1/2010 MT212948 3/1/2010 MT213035 4/30/2010 MT213106 5/31/2010 MT213151 6/30/2010 MT213212 6/30/2010 MT213343 7/31/2010 MT213371 8/31/2010. 
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Christiana Bielinski
908-218-2553
Manufacturer Reason
for Recall		 There is the potential for the duckbill seal to become dislodged.
FDA Determined
Cause 2		 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 in Commerce 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, New Zealand, Puerto Rico, Reunion, Russian Federation, Sweden, Slovina, Turkey, Saudi Arabia, Venezuela and S. Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HET and Original Applicant = ETHICON, INC.
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