FDA Device recall Z-0440-2013

Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endos…

FDA Device
Class II
terminated
Published 2012-12-05

On 2012-12-05 the FDA classified a Class II recall of Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endos… by Cooper Surgical, citing excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0440-2013
Classification	Class II
Status	terminated
Initiated	2012-10-31
Published	2012-12-05
Last updated	2026-09-13 11:53 UTC
Company	Cooper Surgical
Distribution	US

Product

Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Reason

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

Identifiers

code_info	Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0440-2013%22

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