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PRECICE® Bone Transport System BT10-90SJ340-5Recalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · Antegrade Tibia 10° Bend – Three Holes, 10.0mm x 340mm, 5/9cm 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
2
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517979797), received between Feb 4, 2021 and Feb 16, 2021 — classified as 2 injuries.

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-1324-2021 · 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-1323-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Bone Fracture(s)1
  • Skin Discoloration1

Recent adverse event reports

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

  • InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021 IN ORDER TO PLACE A NEW TRANSPORT SCREW AND PERFORM A NEW OSTEOTOMY. IT WAS ALSO REPORTED THAT THERE WAS A FRACTURE OF THE BONE TRANSPORT AT THE DOCKING SITE SEGMENT DUE TO POOR BONE QUALITY.

    Patient problems: Bone Fracture(s)

    MAUDE report 11336194 ↗
  • InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. AS PER THE REPORTER, THE SURGEON OBSERVED BLACK STAINS ON THE PATIENT'S SKIN. TISSUE SAMPLES WILL BE TAKEN AND RESULTS WILL BE PROVIDED. THERE WAS NO HARM OR PATIENT INJURY REPORTED.

    Patient problems: Skin Discoloration

    MAUDE report 11281286 ↗

Other Rod, Fixation, Intramedullary And Accessories devices

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Sources and updates

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