510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0903-2014Class II

Neptune 2 Rover Ultra Waste Management System

Stryker Corp. / initiated 2013-12-30 / Terminated / root cause: design

Stryker Instruments Div. of Stryker Corporation began a recall of Neptune 2 Rover Ultra Waste Management System on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0903-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
Product
Neptune 2 Rover Ultra Waste Management System
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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.
Root cause tag
design
FDA root cause
Device Design
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]
Distribution
Nationwide and Canada, Germany, Australia, New Zealand
Product codes and lots
Manufacturer Part Number 0702-002-000 (230V) All serial numbers

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0903-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0902-2014Class IITerminatedVoluntary: Firm initiated
Z-0903-2014Class IITerminatedVoluntary: Firm initiated