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Terminated

Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1

FDA Recall Z-1019-04 · Posted 2004-07-20

Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeFTL
Date Initiated2003-07-28
Date Terminated2004-06-22
Product Quantity62 units

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.

Firm Action

The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement.

Root Cause

Other

Distribution Pattern

The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023516MONARC SLING SYSTEMAmerican Medical Systems, Inc. · 2002-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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