PRECICE® Intramedullary Limb Lengthening System P12.5-80E245Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812258020897), received between Nov 24, 2020 and Dec 7, 2020 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionDec 7, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE NAIL WAS DISTRACTED 80MM PRIOR TO BEING IMPLANTED AND AFTER BEING DISTRACTED THE NAIL WOULD NOT RETRACT. REPORTEDLY, THE NAIL MADE A "CLICK" NOISE AND THE ONLY WAY THE NAIL WOULD WOULD RETRACT WAS TO PUT EXTRA FORCE BY HAND IN ADDITION TO UTILIZING THE FAST DISTRACTION. ONCE THIS OCCURRED, THE NAIL MADE A "CLICK" NOISE AGAIN AND THE NAIL WAS FUNCTIONAL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10956395 ↗
• MalfunctionNov 24, 2020Mechanical Problem; Mechanical Problem

  REPORT HAS BEEN UPDATED FOR CORRECTION OF REPORTED EXPLANT DATE. INFORMATION WAS RECEIVED THAT THE NAIL WAS NOT EXPLANTED DURING THE REVISION PROCEDURE. THE PATIENT IS STILL TRANSPORTING AND IS IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 10893011 ↗