Z-0458-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 12, 2022
- Initiation Date
- November 22, 2021
- Termination Date
- August 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 devices
Product Description
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Reason for Recall
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Code Information
Lot numbers UM00794 and UM00817, UDI 00180668000106