PRECICE® Intramedullary Limb Lengthening System P8.5-50M165Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812258028237), received between Mar 10, 2021 and Apr 9, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION AVAILABLE. COMPLAINT 2 OF 3.

  Patient problems: Bone Fracture(s)

  MAUDE report 19075183 ↗
• InjuryAug 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT THE NAIL DISASSEMBLED DURING EXPLANTATION AND SUBSEQUENTLY THE FEMORAL BONE NEEDED TO BE FENESTRATED DUE TO BONE DAMAGE INCURRED DURING THE REMOVAL PROCESS. THE DISTAL PORTION OF THE DISASSEMBLED NAIL WAS UNABLE TO BE REMOVED FROM THE INTRAMEDULLARY CANAL AS IT WAS REPORTEDLY TOO TIGHT IN THE BONE. DUE TO THE BONE FENESTRATION, THE PATIENT'S HOSPITAL STAY WAS EXTENDED SIX WEEKS AND REQUIRED THE PATIENT TO WALK WITH FOREARM SUPPORT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17614745 ↗
• MalfunctionAug 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17492669 ↗
• MalfunctionMar 10, 2021Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED THAT AN ANTEGRADE NAIL WAS PUT IN RETROGRADE AND IT WAS NOTICED DURING A FOLLOW UP X-RAY THAT THE NAIL WAS NOT WORKING PROPERLY. AS A RESULT A REVISION PROCEDURE WAS PERFORMED AND A NEW NAIL WAS IMPLANTED. IT WAS NOTED THE NEW NAIL IS WORKING AS INTENDED.

  Patient problems: Failure of Implant

  MAUDE report 11457763 ↗