The Recall Desk
ModerateFDA (Devices)·Z-0122-2013·Announced 2012-10-31

Orthosensor Recalls Knee Trial Software Due to Signal Interference

Orthosensor is recalling 9 units of Knee Trial software version 1.82 because metal objects in the operating room obstruct the line of sight between the knee balancer and the Link station.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves signal interruption due to environmental factors (metal obstruction) rather than a direct structural defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Orthosensor, a manufacturer based in Sunrise, Florida, is recalling nine units of the Graphics User Interface Software version 1.82 for the Knee Trial for Trithion. The software is used in conjunction with the knee balancer device and is loaded onto Link stations. The product is made exclusively for Stryker Orthopaedics and is distributed nationwide, including in California, Florida, Michigan, and New York.

The recall was initiated following customer feedback indicating that the line of sight between the knee balancer and the Link station was obstructed by metal stands or trays in the operating room. Additionally, the knee balancer device was sometimes placed atop or near these metal objects, which interrupted the signal. The software version 1.82 was validated on February 13, 2012.

Healthcare facilities that have received this software should stop using it and contact Orthosensor for instructions on how to proceed. The recall is limited to the specific software version and the associated hardware configuration described in the notice.

The recalled product

Product
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the grap
Manufacturer
Orthosensor
Category
Medical Device — Surgical Software
Hazard
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Version 1.82

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

Same hazard · signal interference

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