Home / Recalls / Orthosoft, Inc. dba Zimmer CAS / Z-0721-2022

Z-0721-2022 Class II Ongoing

Recalled by Orthosoft, Inc. dba Zimmer CAS — Montreal

Recall Details

Product Type
Devices
Report Date
March 9, 2022
Initiation Date
January 7, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 units US; 132 units OUS

Product Description

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

Reason for Recall

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.

Code Information

Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1

Other recalls by Orthosoft, Inc. dba Zimmer CAS

  • Z-1868-2017 Class II — SmartTools Knee System Orthopedic Stereotaxic Instrument (February 20, 2017)
  • Z-1881-2017 Class II — Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Sof (October 6, 2011)
  • Z-2048-2017 Class II — NDI P7 Position Sensor, Stereotaxic Instrument (June 9, 2009)
  • Z-2076-2017 Class II — Navitrack System - OS Knee Universal, Stereotaxic instrument (October 28, 2008)
  • Z-2075-2017 Class III — Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument (June 20, 2008)
  • Z-2227-2017 Class II — Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used (June 4, 2008)