Class 2 Device Recall Stryker Neptune 3 Rover

• Date Initiated by Firm: July 01, 2016
• Date Posted: August 23, 2016
• Recall Status: Terminated on June 02, 2017
• Recall Number: Z-2630-2016
• Recall Event ID: 74759
• 510(K)Number: K153407
• Product Classification: Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
• Product: 120 V Neptune 3 Rover, Model Number: 0703-001-000
• Code Information: 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
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kelly Jo Davis; 269-389-2921
• Manufacturer 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 Determined 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 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
• Quantity in Commerce: 78
• Distribution: Domestic:MI, CA, ID, IA VA/DOD: None Foreign: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JCX