FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
- Recall number
- Z-0795-2007
- Recalling firm
- Ethicon, Inc.
- Product
- Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
- Status
- Terminated
- Initiated
- 2007-04-20
- Posted
- 2007-05-10
- Terminated
- 2008-03-04
- Reason
- The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)
- Root cause
- Other
- Action
- Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers.
- Quantity
- 160 units to US
- Distribution
- Nationwide
- Lot, serial or model codes
- Product Code PFRT01 Lot Number 2990052 2007-12
- 510(k) numbers
- ["K013718"]
- PMA numbers
- not on file
- Product code
- FTM
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28