Z-0488-2021 Class II Terminated
FDA device recall Z-0488-2021 was initiated by Coloplast Manufacturing US, LLC on October 23, 2020 and is designated Class II. Reason for recall: Potential increased occurrence of pump fracture over the lifetime of the device. The recall status is terminated (terminated May 13, 2021). Affected quantity: 8,962 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2020
- Initiation Date
- October 23, 2020
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,962 units
Product Description
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Reason for Recall
Potential increased occurrence of pump fracture over the lifetime of the device.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of DK, ES, JP.
Code Information
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