Recall Z-0454-2013 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Stryker Instruments Div. of Stryker Corporation
Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, 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 dis
| Date | Dec 3, 2012 (initiated May 24, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | Stryker Instruments sent a "STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to sales.service@stryker.com. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052. |
| Quantity | 5865 |
| Distribution | Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.