Z-2630-2016Class II

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

Name: Z-2630-2016 120 V Neptune 3 Rover, Model Number: 0703-001-000
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-07-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-07-01 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 120 V Neptune 3 Rover, Model Number: 0703-001-000 on 2016-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2630-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-08-23
Terminated: 2017-06-02
Recalling firm: Stryker Corp.
Product: 120 V Neptune 3 Rover, Model Number: 0703-001-000
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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.
FDA root cause: Under Investigation by firm
Action: Stryker Instruments initiated a voluntary recall of the Stryker Neptune 3 Rover via certified mail on 07/01/2016, due to the potential for the Neptune 3 Rover to experience system errors if there are high levels of electromagnetic interference in the operating room. 1. Immediately review the Recall Notification. 2. Confirm that the Rover serial numbers identified on the Business Reply Form (BRF) are at your facility. 3. A Stryker representative will facilitate the repair of your affected Neptune 3 Rover(s). Please coordinate the availability of the product to assure the repair can be implemented. 4. Please complete and return the Business Reply Form (BRF). Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 5. Fax the completed, signed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to [email protected]. 6. Stryker will document the repair of each unit by serial number. For questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis 269-389-2921 [email protected]
Quantity in commerce: 78
Distribution: Domestic:MI, CA, ID, IA VA/DOD: None Foreign: None
Product codes and lots: 120 V Neptune 3 Rover, Model Number: 0703-001-000; Serial Numbers: 1606300523, 1610606263, 1610903973, 1610904293, 1612303683, 1612303823, 1612303963, 1606300553, 1610606273, 1610904063, 1610904313, 1612303703, 1612303833, 1612303973, 1606300583, 1610606303, 1610904083 , 1610904343, 1612303713, 1612303843 , 1612303993, 1606300593, 1610606323, 1610904103, 1610904353, 1612303723, 1612303853 , 1613106443, 1606300613, 1610606353, 1610904123, 1610904363 , 1612303733, 1612303863, 1613106463, 1606300623, 1610619473, 1610904163, 1610904373 , 1612303743, 1612303873, 1613106583, 1606300643, 1610619483, 1610904173, 1610904403, 1612303763 , 1612303883 , 1613201233, 1606300653, 1610619543, 1610904183, 1612303633, 1612303783, 1612303903, 1613201243 , 1607503463 , 1610619573 , 1610904193, 1612303643, 1612303793, 1612303913, 1613201303, 1607503493, 1610619603 , 1610904203, 1612303663, 1612303813, 612303933, 1613201323, 1610409473, 1610903893, 1610904213, 1612303673

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2630-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2630-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23

Product code JCX

K153407Class IIStryker Neptune 3 Waste Management SystemStryker Corporation / cleared 2016-04-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)