Product Wiki · Recalls · Health Canada — Medical Devices

Titan® Inflatable Penile Prosthesis — recall 74577

Health Canada — Medical Devices · Canada · 2023-11-10 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74577
Date of alert
2023-11-10
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: Pump bulbs are manufactured using 2 molds. A component on one of the two molds shifted during production. This resulted in a gradual build of material on the mold, which gradually decreased wall thickness of the pump. This occurred over the course of several weeks, culminating in a period of time (17 September 2022 to 02 December 2022) where pump bulbs were manufactured below the wall thickness specification. Recall Start Date: October 30, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/titanr-inflatable-penile-prost

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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