"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass… — Class II medical device recall Z-0122-2013
Terminated recall by Orthosensor, reported 2012-10-31, distributed nationwide. Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to versio
| Recall number | Z-0122-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosensor, Sunrise, FL, United States |
| Recall initiated | 2012-02-04 |
| Classified | 2012-10-24 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2012-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 9 |
| Reason classes | software |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0122-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.