Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a J
FDA device recall Z-0173-2010 · posted 2009-11-10 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- There is the potential for the duckbill seal to become dislodged.
- Action taken
- 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
- Status
- Terminated
- Product code
- HET
- Quantity affected
- 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, Unite
- Date initiated
- 2009-09-28
- Date posted
- 2009-11-10
- Date terminated
- 2010-08-02
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R (K061050) | ETHICON, Inc. | 2006-07-14 |