Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1363-2023 — Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

U.S. FDA — Device Enforcement · United States · 2023-03-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1363-2023
Date of alert
2023-03-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Coloplast Manufacturing US, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05708932072557
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.