Recall Z-0455-2013— Stryker Instruments Div. of Stryker Corporation

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2011-05-24, terminated 2014-05-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.. Reason: Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain..

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Classification

Class II

Status

Terminated

Initiated

2011-05-24

Terminated

2014-05-28

Firm location

Portage, MI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.