Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
FDA device recall Z-1019-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- American Medical Systems
- Reason for recall
- Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.
- Action taken
- The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 62 units
- Distribution
- The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.
- Date initiated
- 2003-07-28
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-22
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONARC SLING SYSTEM (K023516) | American Medical Systems, Inc. | 2002-11-19 |