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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Orthosensor
- 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
Related recalls
Same hazard · signal interference
See all →- HighMedtronic Insertable Cardiac Monitor May Fail to Record Heart Rhythms
FDA (Devices) · 2023-12-06
- HighBoston Scientific Recalls CLEARSIGN II Amplifiers Due to ECG Signal Interference
FDA (Devices) · 2015-06-24
- HighGE Healthcare Recalls Dash Patient Monitors Due to ECG Noise
FDA (Devices) · 2014-01-29
Similar recalls
- ModerateOrthosensor Recalls Verasense Knee System Due to Inoperable Sensor Pad
FDA (Devices) · 2015-02-04
- SevereStryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues
FDA (Devices) · 2013-04-24
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12
- HighStryker Recalls Triathlon Knee Baseplates Due to Manufacturing Defect
FDA (Devices) · 2021-03-17
- HighFDA Recalls 84 Zimmer CAS SmartTools Knee System Instruments
FDA (Devices) · 2017-04-26
- ModerateZimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies
FDA (Devices) · 2017-05-24