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Orthosoft, Inc. Recalls
7 recalls on record · April 26, 2017 to March 9, 2022 · Medical Devices
Recalls by year
17
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 9, 2022Medical DevicesFDA
Orthosoft, Inc. dba Zimmer CAS recalls NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Hazard: 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.
June 14, 2017Medical DevicesFDA
Orthosoft, Inc. dba Zimmer CAS recalls Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of
Hazard: Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.
May 24, 2017Medical DevicesFDA
Orthosoft, Inc. dba Zimmer CAS recalls Navitrack System - OS Knee Universal, Stereotaxic instrument
Hazard: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .
May 24, 2017Medical DevicesFDA
Orthosoft, Inc. dba Zimmer CAS recalls Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Hazard: ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
May 17, 2017Medical DevicesFDA
Orthosoft, Inc. dba Zimmer CAS recalls NDI P7 Position Sensor, Stereotaxic Instrument
Hazard: Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.
May 3, 2017Medical DevicesFDA
Orthosoft, Inc. dba Zimmer CAS recalls Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in
Hazard: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
April 26, 2017Medical DevicesFDA
Orthosoft, Inc. dba Zimmer CAS recalls SmartTools Knee System Orthopedic Stereotaxic Instrument
Hazard: There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P