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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune 2 Rover Ultra

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  Class 2 Device Recall Neptune 2 Rover Ultra see related information
Date Initiated by Firm May 24, 2011
Date Posted December 03, 2012
Recall Status1 Terminated 3 on May 28, 2014
Recall Number Z-0454-2013
Recall Event ID 63634
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
Product 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 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.
Code Information Part 0702-001-000 (120v)   Lot 0733700353 through 1036100423
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact K. Kelly Smith
269-389-3584
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 5865
Distribution Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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