PRECICE® Intramedullary Limb Lengthening System P10.7-50E215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812258020804), received between Feb 29, 2024 and Sep 15, 2025 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PRECISE NAIL WAS BROKEN WHEN IT WAS INCORRECTLY COMPRESSED, IT WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057358 ↗
• InjuryApr 2, 2024Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT AFTER IMPLANTING THE NEW NAIL, AN INTRAOPERATIVE TEST WAS PERFORMED AND THE NAIL WAS NOT FUNCTIONING. THE SURGEON OPENED THE OSTEOTOMY SITE TO ASSURE IT WAS COMPLETE AND FREED ANY SOFT TISSUE ATTACHMENTS THAT MAY HAVE BEEN INTERFERING WITH NAIL FUNCTION, HOWEVER, THE NAIL WAS STILL UNABLE TO MOVE AND WAS THEN EXPLANTED. NAIL FUNCTIONALITY WAS CONFIRMED ON THE BACK TABLE AND WAS THEN REIMPLANTED. AFTER FURTHER OSTEOTOMY SITE AND SOFT TISSUE MANIPULATION THE NAIL WAS ABLE TO SUCCESSFULLY MOVE THE INTERCALARY SEGMENT. THE NAIL WAS TESTED BACK AND FORTH A FEW TIMES TO CONFIRM FUNCTIONALITY ONCE AGAIN AND IT DID NOT WORK. THE NAIL WAS THEN EXPLANTED AND REPLACED. PER THE REPORTER, THE EXPLANATION FOR THESE ISSUES IS SOME SORT OF UNKNOWN PATIENT ANATOMY THAT PREVENTED THE TRANSPORT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19020633 ↗
• InjuryFeb 29, 2024Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED CLICKING SOUNDS FROM THE NAIL DURING DISTRACTION SESSIONS. X-RAYS REPORTEDLY SHOWED SIGNS OF PRECONSOLIDATION WHICH WERE CONFIRMED DURING A REVISION PROCEDURE ON (B)(6) 2024 IN WHICH THE SURGEON REMADE THE OSTEOTOMY AND CHECKED THE NAIL INTRA-OPERATIVELY FOR FUNCTIONALITY. THE NAIL APPEARED TO BE WORKING, HOWEVER, A FEW WEEKS FOLLOWING THE PROCEDURE, THE PATIENT HAD NOT DISTRACTED MORE THAN 1-2MM AS SEEN VIA X-RAY. THE PATIENT THEN UNDERWENT ANOTHER REVISION PROCEDURE IN WHICH THE NAIL WAS REPLACED A NEW NAIL.

  Patient problems: Failure of Implant

  MAUDE report 18807596 ↗