Home / Recalls / Orthosensor, Inc. / Z-1029-2015

Z-1029-2015 Class II Terminated

Recalled by Orthosensor, Inc. — Sunrise, FL

Recall Details

Product Type
Devices
Report Date
February 4, 2015
Initiation Date
December 5, 2014
Termination Date
March 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 devices

Product Description

Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

Reason for Recall

Presence of one inoperable (dead) sensor pad.

Distribution Pattern

US Distribution to the states of : IL, MI, NY, CA, VA and NV.

Code Information

Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.

Other recalls by Orthosensor, Inc.

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