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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune 2 Rover

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 Class 2 Device Recall Neptune 2 Roversee related information
Date Initiated by FirmDecember 30, 2013
Date PostedJanuary 31, 2014
Recall Status1 Terminated 3 on January 12, 2016
Recall NumberZ-0903-2014
Recall Event ID 67191
510(K)NumberK132671 
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
ProductNeptune 2 Rover Ultra Waste Management System
Code Information Manufacturer Part Number 0702-002-000 (230V) All serial numbers
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact
269-323-7700
Manufacturer Reason
for Recall		The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.
FDA Determined
Cause 2		Device Design
ActionOn 12/30/13, Stryker sent an URGENT MEDICAL DEVICE UPDATE notification to consignees including government accounts and Sales Representatives, Stryker Canada and 3 in-house accounts and 1 account for lost rovers. Domestic and government consignees were sent the notification by mail FedEx overnight, and Sales Representatives and Stryker Canada were sent the notification by email. Notification described the affected product, instructions for the consignees, and upgrade information. Stryker also stated that a training kit and in-servicing will be provided to consignees. For questions regarding this recall, please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Neptune Customer Care Center 855-458-7441 or 269-389-2316 strykerinstrumentsrecalls@stryker.com
DistributionNationwide and Canada, Germany, Australia, New Zealand
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JCX
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