Recall Z-1366-2023 ยท FHW Device, Impotence, Mechanical/Hydraulic
Coloplast Manufacturing US, LLC
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
| Date | Apr 12, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| 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 urology@coloplast.com. |
| Quantity | 0 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.