FDA Device recall Z-0209-2015
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850 by American Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0209-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-10 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 86559300…Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 865593007 865869024 865882006 867705012 868952010 868961016 868962022 868964021 869672008 869673021 869683007 870935011 870935017 870936016 870936023 870937001 870938022 870940022 871927006 871927014 871930002 873243013 873243015 873247017 873253025 873944005 873945017 873946003 873949005 873950009 873951024 873952024 875055017 875060017 875060024 876016019 876025002 877253005 877259010 878159022 878160012 878162016 878164009 878165016 878168017 878168021 878975023 880215004 880217014 881145009 881146023 881149014 881150018 881152025 882234015 882236002 882239002 882240012 882241016 882243015 882245014 883312010 883313020 883315019 883319013 883319014 883319015 884416007 884416024 884420017 884422015 884422018 884423025 885166007 885166024 885170004 885170022 886256007 886256021 886257022 886260022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0209-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.