Home / Recalls / Orthosensor, Inc. / Z-0087-2019

Z-0087-2019 Class II Terminated

Recalled by Orthosensor, Inc. — Dania, FL

Recall Details

Product Type
Devices
Report Date
October 17, 2018
Initiation Date
July 12, 2018
Termination Date
June 27, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
68 devices

Product Description

OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.

Reason for Recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Distribution Pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

Code Information

Lot numbers 20566, 20567, 20609, and 20611, UDI 00816818021461.

Other recalls by Orthosensor, Inc.

  • 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)
  • Z-0122-2013 Class II — "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate (February 4, 2012)