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

FDA device recall Z-2630-2016 · posted 2016-08-23 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

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 kellyjo.davis@stryker.com. 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 kellyjo.davis@stryker.com

Root cause

Under Investigation by firm

Status

Terminated

Product code

JCX

Quantity affected

78

Distribution

Domestic:MI, CA, ID, IA VA/DOD: None Foreign: None

Date initiated

2016-07-01

Date posted

2016-08-23

Date terminated

2017-06-02

Location

Portage, MI

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