Z-1359-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- March 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Code Information
UDI/DI 05708932533966, Lot Numbers: 8849559, 8849560, 8849623, 8887867, 8849624, 8497256, 8904186