Device product
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Z-0458-2022
Product summary
- Firm
- Uromedica Inc.
- Event
- Event 89184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 devices
- Official record key
device-enforcement:Z-0458-2022
Official wording
Reason: The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Code information: Lot numbers UM00794 and UM00817, UDI 00180668000106
Distribution pattern: US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Derived failure modes
-
Unknown
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.