Home / Recalls / Orthosensor / Z-0122-2013

Z-0122-2013 Class II Terminated

Recalled by Orthosensor — Sunrise, FL

Recall Details

Product Type
Devices
Report Date
October 31, 2012
Initiation Date
February 4, 2012
Termination Date
December 12, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9

Product Description

"****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

Distribution Pattern

Nationwide Distribution including the states of CA, FL, MI and NY.

Code Information

Version 1.82

Other recalls by Orthosensor

  • Z-0087-2019 Class II — OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCR (July 12, 2018)
  • Z-0086-2019 Class II — OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRG (July 12, 2018)
  • Z-0082-2019 Class II — OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCRE (July 12, 2018)
  • Z-0084-2019 Class II — OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD (July 12, 2018)
  • Z-0083-2019 Class II — OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCR (July 12, 2018)
  • Z-0085-2019 Class II — OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRC (July 12, 2018)
  • Z-1029-2015 Class II — Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert (December 5, 2014)