The Recall Desk

Manufacturer

Orthosoft, Inc. dba Zimmer CAS

7 recalls in our database name Orthosoft, Inc. dba Zimmer CAS as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2022-03-09

Of the 7 recalls from Orthosoft, Inc. dba Zimmer CAS we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-0721-2022·2022-03-09

    Surgical knee navigation implant recalled over sterilization failures

    Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.

    Product
    NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2017·2017-06-14

    Zimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability

    Zimmer CAS is voluntarily recalling 10 Sesamoid Plasty workstations because the top of the unit may fall over during disassembly.

    Product
    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2076-2017·2017-05-24

    Zimmer CAS Recalls Navitrack System OS Knee Universal Software

    Zimmer CAS is voluntarily recalling Navitrack System OS Knee Universal software versions due to software issues causing errors and discrepancies.

    Product
    Navitrack System - OS Knee Universal, Stereotaxic instrument
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2075-2017·2017-05-24

    Zimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies

    Zimmer CAS is voluntarily recalling 152 units of the Navitrack System - OS Knee Universal due to software anomalies corrected in a new revision.

    Product
    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2048-2017·2017-05-17

    Zimmer CAS Recalls NDI P7 Position Sensors for Potential Malfunction

    Zimmer CAS is recalling 34 NDI P7 Position Sensors due to a manufacturing issue that may cause them to stop functioning during use.

    Product
    NDI P7 Position Sensor, Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1881-2017·2017-05-03

    Zimmer CAS Recalls Navitrack Knee Software Due to Calibration Crash

    Zimmer CAS is recalling Navitrack System - OS Knee Universal software due to a calibration sequence crash. The recall affects 105 units distributed worldwide.

    Product
    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1868-2017·2017-04-26

    FDA Recalls 84 Zimmer CAS SmartTools Knee System Instruments

    Orthosoft, Inc. dba Zimmer CAS is recalling 84 SmartTools Knee System Orthopedic Stereotaxic Instruments due to complaints of bent or broken Drive Pins.

    Product
    SmartTools Knee System Orthopedic Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide