Device recall

Z-0458-2022: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041…

FDA device recall · Class II · Uromedica Inc.

Key facts

Recall number (Z-number) Z-0458-2022
Recall event 89184
Product UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Product code EZY
Recalling firm Uromedica Inc.
Recall class Class II
Status Terminated
Termination date Aug 11, 2023
PMA numbers P130018
FEI number 3003477176

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)