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PRECICE® Intramedullary Limb Lengthening System P10.7-80C245Recalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 245 mm length · Class 2 · Implant

All models of PRECICE Intramedullary Limb Lengthening System (551)

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 00812258020453), received between Feb 26, 2020 and Mar 8, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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. Oct 29, 2021Class IIOpen, Classified

    The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

    Z-0319-2022 · Root cause: Device Design · Recall details · FDA record ↗

  2. Feb 12, 2021Class IIOpen, Classified

    Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

    Z-1349-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Defective Component1
  • Failure to Advance1
  • Mechanical Problem1
  • Use of Device Problem1

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.

  • InjuryMar 8, 2021Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT'S CAREGIVERS HAD BEEN UTILIZING THE EXTERNAL LENGTHENING CONTROLLER IN THE WRONG DIRECTION (I.E. SHORTENING INSTEAD OF LENGTHENING). DURING THE REVISION PROCEDURE, IT WAS FOUND THE NAIL WOULD NO LONGER LENGTHEN AND IT WAS REMOVED AND REPLACED WITH AN EXTERNAL FIXATION.

    Patient problems: Failure of Implant

    MAUDE report 11439897 ↗
  • MalfunctionMar 17, 2020Defective Component; Defective Component

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER REPORTER, THE NAIL FAILED TO LENGTHEN.

    Patient problems: Failure of Implant

    MAUDE report 9838903 ↗
  • MalfunctionFeb 26, 2020Failure to Advance; Failure to Advance

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

    Patient problems: Failure of Implant

    MAUDE report 9758606 ↗

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