Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
This recall is currently active, issued April 12, 2023. It was issued by Coloplast Manufacturing Us, Llc.
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- March 1, 2023
- Posted
- April 12, 2023
- Recall Number
- Z-1374-2023
- Quantity
- 20 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
XXX
Distribution
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Lot / Code Info
UDI/DI 05708932487368, Lot Numbers: 8849601, 8849600, 8849621
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.