PRECICE® Intramedullary Limb Lengthening System P8.5-80D245Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00812258020606), received between May 17, 2016 and Jan 9, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Material Twisted/Bent

  IT WAS REPORTED BY THE SURGEON THAT THE PRECICE NAIL IS VERY BENT AND REQUIRES REVISION SURGERY TO REPLACE NAIL. THE NAIL REMAINS IN SITU WITH PLAN FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021669 ↗
• MalfunctionNov 10, 2025Failure to Advance; Failure to Advance

  PRECICE NAIL WAS TESTED WITH FAST DISTRACTOR, AND THE NAIL DID NOT MOVE. WE TRIED SEVERAL TIMES AND SUDDENLY THE THINNER PART OF THE NAIL PLOBBED OUT ABOUT 2CM. AFTER THAT, YOU COULD BY HAND MOVE THE THINNER PART OF THE NAIL BACK AND FORTH. THE NAIL WAS REPLACED WITH A NEW WORKING PRECICE NAIL WITH REPORTED GOOD OUTCOME. THIS REVISION TOOK PLACE ON (B)(6) 2025. THIS EVENT OCCURRED IN GERMANY.

  Patient problems: Failure of Implant

  MAUDE report 23513257 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  PATIENT OF 15 YEARS OLD DID FALL AND BREAK HIS BONE INCLUDING THE PRECICE NAIL IN THIS EVENT. REVISION HAS TAKEN PLACE ON (B)(6) 2025 WITH A STD TRAUMA NAIL. THE LENGTHENING HAS BEEN ACHIEVED WITH THE PRECICE NAIL. THEREFORE, A TRAUMA NAIL HAS BEEN PLACED FOR HEALING AFTER THE BREAK CAUSED BY THE PATIENT'S FALL. THIS EVENT TOOK PLACE IN THE NETHERLANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23455532 ↗
• MalfunctionSep 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A REVISION SURGERY OCCURRED TO REMOVE A PRECICE NAIL THAT HAD BROKEN POST OPERATIVELY. THIS EVENT OCCURRED IN THE NETHERLANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006170 ↗
• InjuryJan 25, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18582650 ↗
• InjuryDec 12, 2023Break; Break

  INFORMATION WAS RECEIVED THAT THE PATIENT WAS WEIGHTBEARING DAILY AND THEY FELT A SNAP. THE NAIL SUBSEQUENTLY BROKE AND THE PATIENT REQUIRED A REVISION PROCEDURE TO REMOVE THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18312411 ↗
• MalfunctionAug 23, 2023Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17608350 ↗
• MalfunctionOct 18, 2022Break; Break

  INFORMATION WAS RECEIVED THAT THE NAIL HAD TO BE EXPLANTED DUE TO AN ALLEGED BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627093 ↗
• MalfunctionMay 27, 2022Fracture; Unintended System Motion; Fracture; Unintended System Motion

  INFORMATION WAS RECEIVED THAT THE PATIENT FELT A CLICK AND PAIN THAT LASTED 24 HOURS. DURING A FOLLOW-UP APPOINTMENT, THE SURGEON NOTICED THE NAIL WAS SHORTENING AND WAS FOUND TO BE BROKEN. THE NAIL WAS REMOVED. HOWEVER; SMALL PIECES OF THE NAIL WERE LEFT IN THE MEDULLARY CANAL DURING REMOVAL. THE SURGEON BELIEVES THE PATIENT WAS FULL WEIGHT BEARING. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: Pain

  MAUDE report 14525933 ↗
• InjuryMar 18, 2022Defective Component

  THE PATIENT HAS A HISTORY OF A LIMB LENGTH DISCREPANCY THAT HAS BEEN TREATED WITH A LENGTHENING ROD IN THE PAST. A LENGTHENING ROD WAS RECENTLY PLACED ON (B)(6) 2022 AND THE ROD ITSELF WAS FOUND TO BE MALFUNCTIONING. OPTIONS WERE DISCUSSED AND BECAUSE IT HAD BEEN A COUPLE OF WEEKS, IT WAS DECIDED TO REMOVE AND EXCHANGE THE ROD AND ALSO MAKE SURE THAT THE OSTEOTOMY WAS COMPLETE, SO THE LEG WOULD BE APPROPRIATELY LENGTHENED. THE DEFECTIVE ROD WAS REMOVED AND REPLACED ON (B)(6) 2022. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13839961 ↗
• MalfunctionMar 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE ROD/MAGNET FAILING. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737097 ↗
• InjurySep 10, 2019Break; Break

  INFORMATION RECEIVED STATED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019. AS PER REPORTER, PATIENT FELL TWICE DURING THE LENGTHENING PROCESS. NAIL WAS REPORTED TO HAVE BROKEN POST PATIENTS SECOND FALL.

  Patient problems: Bone Fracture(s)

  MAUDE report 8982627 ↗
• InjuryMay 17, 2016Device Operates Differently Than Expected

  A DISTRIBUTOR REPORTED THAT A PATIENT'S PRECICE NAIL WAS REMOVED AFTER APPROXIMATELY ONE (1) MONTH OF IMPLANTATION. THE NAIL ALLEGEDLY APPEARED TO NOT BE LENGTHENING; HOWEVER, THE NAIL LENGTHENED INTRA-OPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 5660020 ↗