PRECICE® Intramedullary Limb Lengthening System P12.5-80B305Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00812258020347), received between Mar 8, 2022 and Apr 23, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Fracture; Break; Fracture

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE OCCURRED DUE TO THE NAIL BEING DAMAGED SURROUNDING THE MALE-FEMALE JUNCTION SITE. THE REVISION PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894440 ↗
• MalfunctionApr 23, 2025Break; Fracture; Break; Fracture

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE OCCURRED DUE TO THE NAIL BEING DAMAGED SURROUNDING THE MALE-FEMALE JUNCTION SITE. THE REVISION PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894324 ↗
• MalfunctionAug 24, 2023Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17612905 ↗
• MalfunctionJul 19, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT THE NAIL BROKE AFTER ONE MONTH. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17352924 ↗
• MalfunctionJun 2, 2023Break; Unintended System Motion; Break; Unintended System Motion

  INFORMATION WAS RECEIVED THAT A FEW MONTHS AGO SOMETHING SNAPPED IN THE PATIENT'S LEG WHILE STRETCHING AND THE PHYSICIAN SUSPECTS A CROWN BREAKAGE. IT WAS ADDITIONALLY REPORTED THAT THE NAIL HAS RECOILED AND CAUSED A ROTATIONAL DEFORMITY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17052303 ↗
• MalfunctionJan 18, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE NAIL DID NOT EXTEND AND WAS REPLACED WITH A NEW ONE.

  Patient problems: Failure of Implant

  MAUDE report 16196538 ↗
• MalfunctionJan 18, 2023Break; Failure to Advance; Break; Failure to Advance

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16196533 ↗
• MalfunctionMar 8, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE FEMALE PART OF THE MALE/FEMALE JUNCTION BROKE ON THE NAIL. NO PATIENT ADVERSE EVENT WAS REPORTED. THE PATIENT RECEIVED A NEW NAIL WITH NO COMPLICATIONS AND IS CONTINUING HIS LENGTHENING SESSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694771 ↗