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Recall Observatory FDA recall evidence

Device product

Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

Z-1374-2023

March 01, 2023

Class II

Product summary

Firm
Coloplast Manufacturing US, LLC
Event
Event 91800
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-1374-2023

Official wording

Reason: XXX

Code information: UDI/DI 05708932487368, Lot Numbers: 8849601, 8849600, 8849621

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX