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

Recall Z-0806-2015 — AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One en

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-0806-2015
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): 878849001

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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