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Terminated

Neptune 2 Rover Ultra Waste Management System

FDA Recall Z-0903-2014 · Posted 2014-01-31

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeJCX
Date Initiated2013-12-30
Date Terminated2016-01-12

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.

Firm Action

On 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 [email protected]

Root Cause

Device Design

Distribution Pattern

Nationwide and Canada, Germany, Australia, New Zealand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132671STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEMStryker Corporation · 2013-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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