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NA 310.15SRecalls & reported problems

Synthes GmbH · 1.5MM DRILL BIT/QC/85MM STERILE · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Jan 24, 2024Open, Classified

    Products not sterilized, sterility cannot be confirmed

    Z-1235-2024 · Root cause: Process control · Recall details · FDA record ↗

Other Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment devices

All Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment devices →

Sources and updates

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