Recall Z-2630-2016— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-2630-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-01

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2016-07-01, terminated 2017-06-02. It names one FDA 510(k) clearance: K153407. Product: 120 V Neptune 3 Rover, Model Number: 0703-001-000. Reason: Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Terminated: 2017-06-02
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K153407 — Stryker Neptune 3 Waste Management SystemStryker Corporation·cleared 2016-04-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

120 V Neptune 3 Rover, Model Number: 0703-001-000

Reason for recall

Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.

Data sourced from openFDA. This site is unofficial and independent of the FDA.