AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part

FDA device recall Z-0209-2015 · posted 2014-11-13 · Terminated

Recall details

Recalling firm

American Medical Systems, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JCW

Quantity affected

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, AUSTR

Date initiated

2014-10-10

Date posted

2014-11-13

Date terminated

2015-09-28

Location

Minnetonka, MN