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ARVIS ® IN-29200Recalls & reported problems

Kico Knee Innovation Company Pty Limited · ARVIS Navigation System, Gen 2, US · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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 still open.

1 other recall cover devices cleared under the same FDA submission (K243950, K243980); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jul 13, 2026Open, Classified

    Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

    Z-2957-2026 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243950, K243980. One submission often covers many models, so check the product and lot details in each record.

  • Z-0145-2026 · Sep 19, 2025 · Open, Classified
    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The

Other Orthopedic Stereotaxic Instrument devices

All Orthopedic Stereotaxic Instrument devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.