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Z-0455-2013 Class II Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-0455-2013 was initiated by Stryker Instruments Div. Of Stryker Corporation on May 24, 2011 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated May 28, 2014). Affected quantity: 154.

Recall details

Product Type: Devices
Report Date: Dec 12, 2012
Initiation Date: May 24, 2011
Termination Date: May 28, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 154

Product description

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 for recall

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.

Distribution pattern

Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.

Code information

Part 0702-002-000 (230v) Lot 0733700353 through 1036100423

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0455-2013
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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