Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- March 1, 2023
- Posted
- April 12, 2023
- Recall Number
- Z-1368-2023
- Quantity
- 8 units
- Firm Location
- Minneapolis, MN
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
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Lot / Code Info
UDI/DI 05708932539142, Lot Numbers: 8849563, 8849585, 8904187
Root Cause
Process change control
Action Taken
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 urology@coloplast.com.