Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0805-2015 — AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless stee

U.S. FDA — Device Enforcement · United States · 2014-10-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0805-2015
Date of alert: 2014-10-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: American Medical Systems, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 72404195

Reported risk: During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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