RecallRadar

FDA Device recall Z-0122-2013

"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com**…

On 2012-10-31 the FDA classified a Class II recall of "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com**… by Orthosensor, citing ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0122-2013
ClassificationClass II
Statusterminated
Initiated2012-02-04
Published2012-10-31
Last updated2026-09-13 11:53 UTC
CompanyOrthosensor
DistributionUS

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 graphic user interface, which is loaded onto the linkstations.

Reason

Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the Link station was obstructed by OR metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru

Identifiers

code_infoVersion 1.82

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0122-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.