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PRECICE® Bone Transport System BT13-10X400-7Recalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · Retrograde Femur Straight, 13.0mm 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
3
Deaths reported
0
Injuries reported
1
Recalls naming it
2

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517977083), received between Apr 27, 2020 and Jun 2, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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

  • Defective Device2
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Failure of Implant3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 2, 2020Defective Device; Defective Device

    SEE UPDATED INFORMATION IN H2, H3, H6 AND H10.

    Patient problems: Failure of Implant

    MAUDE report 10113075 ↗
  • InjuryJun 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE NAIL WOULD NOT TRANSPORT ANY FURTHER.

    Patient problems: Failure of Implant

    MAUDE report 10112945 ↗
  • MalfunctionApr 27, 2020Defective Device; Defective Device

    B.5: SEE UPDATED INFORMATION IN H2, H3, H6 AND H10.

    Patient problems: Failure of Implant

    MAUDE report 10003634 ↗

Other Rod, Fixation, Intramedullary And Accessories devices

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Sources and updates

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