AMS recalls its AdVance Male Sling System
American Medical Systems Europe BV issues a safety notice for its AdVance males slings after receiving customer complaints that the devices' absorbable sutures might prematurely degrade on the shelf.
American Medical Systems (NSDQ:AMMD) Europe BV recalled certain lots of its AdVance Male Sling Systems, warning that the absorbable sutures in the AdVance sling might not last as long as expected on the shelf.
The sutures in the devices, which are labeled with a 15-month shelf-life, may become brittle and easily breakable when the product is flexed prior to surgery. Affected devices may not work properly during the immediate post-operative period if the sutures are weakened, according to the notice.