Recall Z-0209-2015 · JCW Prosthesis, Penis, Inflatable

American Medical Systems, Inc.

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.

Date	Nov 13, 2014 (initiated Oct 10, 2014)
Status	Terminated
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.
Root cause	Nonconforming Material/Component
Action	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 salesoperations@ammd.com.
Quantity	184 (110 US, 74 OUS)
Distribution	Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, GREAT BRITAIN, LEBANON, PANAMA, SOLOMON ISLANDS, SWEDEN, and C
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.