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Open, Classified

Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis

FDA Recall Z-1366-2023 · Posted 2023-04-12

Recalling FirmColoplast Manufacturing US, LLC
Recall StatusOpen, Classified
Product CodeFHW
Date Initiated2023-03-01
Product Quantity0

Reason for Recall

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.

Firm Action

The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air. The notice explained the issue and the hazard to health. The notice requests the removal and return of the affected product. Distributors are instructed to notify their customers. For further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email [email protected].

Root Cause

Process change control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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