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Genius Total Knee System 121-07-3000Recalls & reported problems

Signature Orthopaedics Pty Ltd · Class 2 · Implant

All models of Genius Total Knee System (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K170613); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Dec 10, 2018Class IITerminated

    Product mix up

    Z-0834-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170613. One submission often covers many models, so check the product and lot details in each record.

  • Z-0833-2019 · Dec 10, 2018 · Terminated
    Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page