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UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.

FDA Recall #Z-0458-2022 — Class II — November 22, 2021

Recall #Z-0458-2022 Date: November 22, 2021 Classification: Class II Status: Terminated

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.

Recalling Firm

Uromedica Inc. — Plymouth, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

18 devices

Distribution

US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.

Code Information

Lot numbers UM00794 and UM00817, UDI 00180668000106

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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