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KLS MaxDriver 2 KLS-SD-2000Recalls & reported problems

Pro-Dex, Inc. · Class 1

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.

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. Sep 23, 2024Open, Classified

    The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

    Z-0280-2025 · Root cause: Component design/selection · FDA record ↗

Other Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment devices

All Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment devices →

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