FDA Device recall Z-1365-2023
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400
- FDA Device
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400 by Coloplast Manufacturing Us, citing A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1365-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coloplast Manufacturing Us |
| Distribution | US |
Product
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Reason
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Identifiers
| code_info | UDI/DI 05708932072595, Lot Numbers: 8887620, 8939124 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1365-2023%22
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