FDA Medical Device Recalls (openFDA)
American Medical Systems: Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
- Recall number
- Z-1019-04
- Recalling firm
- American Medical Systems
- Product
- Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
- Status
- Terminated
- Initiated
- 2003-07-28
- Posted
- 2004-07-20
- Terminated
- 2004-06-22
- Reason
- 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.
- Root cause
- Other
- Action
- The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement.
- Quantity
- 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.
- Lot, serial or model codes
- Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)
- 510(k) numbers
- ["K023516"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 1000116179
- Firm city
- Minnetonka
- Firm state
- MN
- 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