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PRECICE® Bone Transport System BT115-10D400-7Recalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · Antegrade Femur Trochanter 10° Bend, 11.5mm x 400mm, 7/10cm ST · Class 2 · Implant

All models of PRECICE Bone Transport System (561)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517979445), received between Oct 15, 2020 and Apr 27, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

2 FDA recall records name this device's identifier, 2 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. Feb 12, 2021Class IIOpen, Classified

    Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

    Z-1323-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Feb 12, 2021Class IIOpen, Classified

    Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

    Z-1324-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Mechanical Problem1

Patient problems

  • Failure of Implant1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 11731736 ↗
  • MalfunctionOct 15, 2020Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE IS PLANNED IN OCTOBER. AS PER THE REPORTER, THE NAIL STOPPED TRANSPORTING.

    Patient problems: Failure of Implant

    MAUDE report 10687872 ↗

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Sources and updates

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