Gynecare PROLIFT Total Pelvic Repair System recallZ-0795-2007 · Ethicon, Inc. · initiated Apr 20, 2007
Terminated All recalls posted in May 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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)
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0795-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 20, 2007
- Posted by the FDA
- May 10, 2007
- Recalling firm
- Ethicon, Inc.
- Quantity
- 160 units to US
- Product code
- FTM
- FDA submissions
- K013718
- Distribution
- Nationwide
Product description
Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
Code information (models, lots, serial numbers)
Product Code PFRT01 Lot Number 2990052 2007-12
Other devices under the same FDA submission
3 devices cleared under K013718 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GYNECARE GYNEMESH GPSLEthicon, LLC · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed164 reports
- GYNECARE GYNEMESH GPSXL3Ethicon, LLC · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed17 reports
- GYNECARE GYNEMESH GPSLEthicon, LLC · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed14 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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