Titan® Inflatable Penile Prosthesis
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
---|---|---|
Titan® Inflatable Penile Prosthesis |
8806754 |
ES2920 |
Issue
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
Additional information
Details
Coloplast A/S
Holtedam 1, Humlebaek, Denmark, 3050
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