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N/A 45S2000Recalls & reported problems

Medtronic Xomed, Inc. · BLADE 45S2000 NUCLEUS REMOVAL STR 4.5MM · 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.

2 other recalls cover devices cleared under the same FDA submission (K081475); 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. Aug 31, 2021Open, Classified

    There was an increase in complaints related to tip breaks and wobble/vibration.

    Z-0158-2022 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081475. One submission often covers many models, so check the product and lot details in each record.

  • Z-0961-2022 · Dec 15, 2021 · Terminated
    Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E
  • Z-2085-2016 · May 13, 2016 · Terminated
    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number:

Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices

All DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices →

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