The Recall Desk

FDA (Devices) recall action 63634

Stryker Instruments Div. of Stryker Corporation recalled 2 products on 2012-12-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-12-12
Critical
0
Units
6,019

Why these products were recalled

Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2012-12-12

    Stryker Neptune 2 Rover Recall Due to Castor Binding Defect

    Stryker is recalling Neptune 2 Rover waste management systems because a castor design defect can cause the unit to bind, potentially leading to operator back pain.

    Product
    Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid was
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-12-12

    Stryker Neptune 2 Rover Recall Due to Binding Casters

    Stryker is recalling 154 Neptune 2 Rover units because a castor design defect can cause binding, leading to operator strain and back pain.

    Product
    Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid wa
    Category
    Distribution
    0 states