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.

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.

Consignees were sent via either Fed Ex mailing or hand delivery by AMS Field Personnel beginning on 10/10/2014 an AMS "Urgent Medical Device Recall" letter dated October 9, 2014. The letter described the problem and the product involved in the recall. Requested consignees to complete and return the Product Recall Acknowledgement Form. For questions consignees can contact AMS Customer Service at 1-800-328-3881 , FAX 1-800-366-9035, ore mail [email protected].