Recall Z-0209-2015— American Medical Systems, Inc.

Class II FDA medical device recall by American Medical Systems, Inc., initiated 2014-10-10, terminated 2015-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.. Reason: AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool..

Recalling firm

American Medical Systems, Inc.

Classification

Class II

Status

Terminated

Initiated

2014-10-10

Terminated

2015-09-28

Firm location

Minnetonka, MN, United States

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