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Terminated

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

FDA Recall Z-0458-2022 · Posted None

Recalling FirmUromedica Inc.
Recall StatusTerminated
Product CodeEZY
Date Initiated2021-11-22
Date Terminated2023-08-11
Product Quantity18 devices

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.

Firm Action

Letters dated 11/22/2021 were issued via email to the consignees explaining the reason for recall. The consignee is requested to identify and remove the affected u-channel sheath and sharp trocar from circulation at their facility. The consignee will be contacted by a Uromedica representative who will schedule an in-person visit and collect the affected U-channel sheath and sharp trocar. Once the instruments have been removed from the facility, replacement instruments will be provided.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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