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InCore Lapidus IC-LAP-28RRecalls & reported problems

Medartis Inc. · InCore Lapidus 5.9mm X 28mm Right Kit · Class 2

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.

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. Mar 26, 2021Terminated

    Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended

    Z-1500-2021 · Root cause: Under Investigation by firm · FDA record ↗

Other Screw, Fixation, Bone devices

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