PRECICE® Intramedullary Limb Lengthening System P10.7-80B305Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00812258020279), received between Apr 23, 2021 and Sep 30, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2025Break; Break

  IMPLANTED PRECISE NAIL BROKEN, REVISION PROCEDURE COMPLETED TO REMOVE AND REPLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183495 ↗
• MalfunctionSep 4, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE TO REMOVE AND REPLACE A PRECICE NAIL THAT FAILED TO DISTRACT.

  Patient problems: Failure of Implant

  MAUDE report 22965065 ↗
• MalfunctionJan 21, 2025Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE PATIENT EXPERIENCING PAIN AND AN X-RAY IMAGE REVEALING A BROKEN NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200478 ↗
• MalfunctionJan 23, 2024Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT THE NAIL DID NOT WORK UPON IMPLANTATION INSIDE THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18566688 ↗
• MalfunctionOct 12, 2023Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17921711 ↗
• InjuryAug 29, 2023Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT 15 DAYS AFTER THE IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE NAIL HAD DISTRACTED VERY LITTLE AND DECIDED THAT THE DISTRACTION OF THE NAIL SHOULD BE ACCELERATED; HOWEVER, AFTER FOLLOW UP, IT WAS NOTICED THAT DISTRACTION HAD COMPLETELY STOPPED. IT WAS THEN DECIDED THAT THE PATIENT SHOULD HAVE ANOTHER PROCEDURE WHERE THE OSTEOTOMY LINE WAS CHECKED AND 1CM LENGTHENING WAS ATTEMPTED AND WAS UNSUCCESSFUL. THE NAIL WAS THEN EXPLANTED, LENGTHENING WAS ATTEMPTED IN THE OPERATING ROOM AGAIN AND WAS SUCCESSFUL. THE NAIL WAS WAS THEN IMPLANTED AGAIN INTO THE PATIENT, HOWEVER, THE NAIL WOULD NOT DISTRACT. IT WAS FINALLY DECIDED THAT THEY WOULD IMPLANT A NEW NAIL.

  Patient problems: Failure of Implant

  MAUDE report 17646958 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION WAS RECEIVED THAT THE PATIENT NOTICED ROTATIONAL SPINNING. THE NAIL HAS BEEN EXPLANTED. THE PATIENT REPORTED EXPERIENCING PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15125577 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION WAS RECEIVED THAT THE PATIENT NOTICED ROTATIONAL SPINNING. THE NAIL HAS BEEN EXPLANTED. THE PATIENT REPORTED EXPERIENCING PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15125499 ↗
• MalfunctionSep 20, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12501931 ↗
• MalfunctionApr 23, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713022 ↗