| Date Initiated by Firm | April 20, 2007 |
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| Date Posted | May 10, 2007 |
|---|
| Recall Status1 |
Terminated 3 on March 04, 2008 |
| Recall Number | Z-0795-2007 |
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| Recall Event ID |
37805 |
| 510(K)Number | K013718 |
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| Product Classification |
Pelvic floor repair system - Product Code FTM
|
| Product | Gynecare PROLIFT Total Pelvic Repair System
PFRT01
Ethicon
Deutschland |
|---|
| Code Information |
Product Code PFRT01 Lot Number 2990052 2007-12 |
Recalling Firm/
Manufacturer |
Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
|
| For Additional Information Contact | Christiana Bielinski
908-253-2553 |
|---|
Manufacturer 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) |
|---|
FDA Determined
Cause 2 | 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. |
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| Quantity in Commerce | 160 units to US |
|---|
| Distribution | Nationwide |
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| 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 = FTM
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