Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
FDA device recall Z-0795-2007 · posted 2007-05-10 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- 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)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 160 units to US
- Distribution
- Nationwide
- Date initiated
- 2007-04-20
- Date posted
- 2007-05-10
- Date terminated
- 2008-03-04
- 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 |
|---|---|---|
| GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR (K013718) | Gynecare, A Div. of Ethicon, Inc. | 2002-01-08 |