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MEDLINE UNITE MPN10013Recalls & reported problems

Medline Industries, Inc. · DRILL BIT, SOLID CORE, 1.3MM · Class 1

All models of MEDLINE UNITE (10)

Data updated Oct 18, 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 18, 2026.

Recalls naming this device

  1. Dec 22, 2022Class IIOpen, Classified

    The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.

    Z-1047-2023 · Root cause: Device Design · Recall details · FDA record ↗

Other REAMER devices

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Sources and updates

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