AMS 700 Series Inflatable Penile Prosthesis Accessory Kit — Class II medical device recall Z-0209-2015
Terminated recall by American Medical Systems, Inc., reported 2014-11-19, distributed nationwide. AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessor
| Recall number | Z-0209-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Medical Systems, Inc., Minnetonka, MN, United States |
| Recall initiated | 2014-10-10 |
| Classified | 2014-11-13 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CO, DE, FR, GB, LB, PA, SE |
| Lot numbers | 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 and 144 more |
| Model numbers | 700 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0209-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.