Z-0122-2013Class II

"**ORTHO SENSOR12-123-A Knee Trial for Trithion1560 Saw grass Corporate Pkwy4Th floor***Sunrise, FL...

Name: Z-0122-2013 "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL...
Creator: Orthosensor
Published: 2012-02-04
License: https://open.fda.gov/license/

Orthosensor, Inc. / initiated 2012-02-04 / Terminated / root cause: software

FDA source

Orthosensor began a recall of "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only***... on 2012-02-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0122-2013
Classification: Class II
Status: Terminated
Initiated: 2012-02-04
Posted: 2012-10-24
Terminated: 2012-12-12
Recalling firm: Orthosensor, Inc.
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.
Product code: ONN Intraoperative Orthopedic Joint Assessment Aid
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
Root cause tag: software
FDA root cause: Software design
Action: Orthosensor did not provide a written customer notification. As the recall was reported to the FDA well after all nine of the products were corrected (the recall stemmed from an initial inspection of the firm), then no customer notification was requested. The removal and replacement of the previous version of the Graphic User Interface Software is being handled internally by members of Operations and the Sales force. The items the firm is recalling is software, and the software cannot be returned; the old version (version 1.8) would be erased. The new version 1.82 would be installed and downloaded into the equipment at the site during servicing. This does not involve the customer of which none are consignees. Effectiveness checks associated with the update of the software is being handled internally by the Operations and the Sales force. Further questions please call (813) 645-2855.
Quantity in commerce: 9
Distribution: Nationwide Distribution including the states of CA, FL, MI and NY.
Product codes and lots: Version 1.82

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0122-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0122-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24

Product code ONN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)