Recall Z-0259-2013— American Medical Systems, Inc.

Name: FDA recall Z-0259-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-19

Class II · Terminated

Class II FDA medical device recall by American Medical Systems, Inc., initiated 2012-10-19, terminated 2013-04-11. It names one FDA 510(k) clearance: K053371. Product: AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).. Reason: American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the.

Recalling firm: American Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-19
Terminated: 2013-04-11
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K053371 — AMS MALE TRANSOBTURATOR SLING SYSTEMAmerican Medical Systems, Inc.·cleared 2006-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).

Reason for recall

American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the

Data sourced from openFDA. This site is unofficial and independent of the FDA.