PRECICE® Intramedullary Limb Lengthening System P10.7-80B275Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00812258020262), received between Dec 6, 2020 and Feb 9, 2026 — classified as 3 injuries, 5 malfunctions.

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

• MalfunctionFeb 9, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A SURGERY TO RECHARGE THE PRECICE NAIL NEITHER THE FAST DISTRACTOR MAX NOR THE ERC WERE ABLE TO RETRACT THE NAIL DESPITE NUMEROUS ATTEMPTS. THE ERC SHOWED THERE WAS A CONNECTION BETWEEN MAGNETS WITH A GREEN CHECK MARK BUT THERE WAS NO ACTUAL MOVEMENT OF THE NAIL. THE NAIL WAS THEN REMOVED AND TESTED ON THE BACK TABLE WITH NO SUCCESS. THE NAIL HAD BEEN EXTRACTED TO 78 MM PRIOR TO THE RECHARGE SURGERY. POST-OP, THE PATIENT REPORTED THAT DURING HIS FINAL DISTRACTIONS WITH THE ERC VIA THE PRESCRIPTION HE WAS HEARING A CLUNKING SOUND. HIS PRESCRIBED TREATMENT WAS .33 MM X 3 TIMES A DAY.

  Patient problems: Failure of Implant

  MAUDE report 24295164 ↗
• InjuryMar 27, 2024Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18988644 ↗
• InjuryJan 23, 2024Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18566217 ↗
• InjuryJan 23, 2024Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18564783 ↗
• MalfunctionMar 9, 2022Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED THAT THE NAIL STOPPED DURING THE LENGTHENING PROTOCOL. PER THE REPORTER, THE NAIL WAS MOVING INSIDE THE BODY PART. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715575 ↗
• MalfunctionMar 8, 2022Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED THAT THE NAIL STOPPED DURING THE LENGTHENING PROTOCOL. PER THE REPORTER, THE NAIL WAS MOVING INSIDE THE BODY PART. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13695361 ↗
• MalfunctionMar 8, 2022Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED THAT THE NAIL STOPPED DURING THE LENGTHENING PROTOCOL. PER THE REPORTER, THE NAIL WAS MOVING INSIDE THE BODY PART. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690369 ↗
• MalfunctionDec 6, 2020Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. AS PER THE REPORTER, THE NAIL BROKE DUE TO WEIGHT BEARING. THE NAIL LENGTHENED SUCCESSFULLY AND WAS REPLACED WITH A STATIC NAIL TO ALLOW FOR CONSOLIDATION OF BONE REGENERATE.

  Patient problems: Failure of Implant

  MAUDE report 10956324 ↗