Device recall: Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
Class I FDA enforcement event 61747. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high…
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Stryker Instruments Div. of Stryker Corporation started this device recall on 8 Jun 2012. The firm address in the FDA record is in Portage, MI. FDA put the recall in Class I. FDA event 61747 has 4 product records. The first FDA enforcement report date is 22 Aug 2012. The record gives the status Terminated, with the termination date 23 Aug 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution -- USA (nationwide) and country of: Canada. .
Recalling firm
Stryker Instruments Div. of Stryker Corporation, Portage, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2061-2012 | Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700 | 2657 | Class I | Terminated | 22 Aug 2012 |
| Z-2062-2012 | Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. | 5925 domestic 2 international | Class I | Terminated | 22 Aug 2012 |
| Z-2063-2012 | Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. | 1075 | Class I | Terminated | 22 Aug 2012 |
| Z-2064-2012 | Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. | 10,394 domestic, 276 international | Class I | Terminated | 22 Aug 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class I
- 5%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 55
Other events of the firm
Stryker Instruments Div. of Stryker Corporation: all 55 events
Official channels
- FDA enforcement report Z-2061-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 61747. https://recallregister.com/fda/i/61747/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution -- USA (nationwide) and country of: Canada. .
- What quantity of product is in FDA event 61747?
- The event has 4 product records. The first record gives this quantity:
2657
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 5% of the 823 device events that started in 2012 are in Class I.