American Medical Systems Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
Brand
American Medical Systems
Lot Codes / Batch Numbers
Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)
Products Sold
Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)
American Medical Systems is recalling Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026