PRECICE® Intramedullary Limb Lengthening System P10.7-80E245Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812258020828), received between Nov 1, 2022 and Dec 18, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PRECICE NAIL WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2025, THE PATIENT WAS ADMITTED FOR AN OSTEOTOMY DUE TO THE BREAKAGE OF THE PRECICE SCREW AND THE DISTAL AND PROXIMAL SCREWS. FRAGMENTS EXTRACTED, AND NAIL WAS REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23842504 ↗
• InjuryOct 3, 2024Break; Break

  INFORMATION WAS RECEIVED THAT THE PATIENT IS UNDERGOING STATURE LENGTHENING WITH RETROGRADE NAILS. IT WAS NOTICED THAT THE CROWN OF BOTH NAILS WERE DISENGAGED WHICH WOULD ALLOW FOR FREE ROTATION OF THE NAIL. AT THIS TIME IT IS UNKNOWN IF A REVISION PROCEDURE HAS BEEN PERFORMED. COMPLAINT 2 OF 2.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 20362299 ↗
• InjuryOct 3, 2024Break; Break

  INFORMATION WAS RECEIVED THAT THE PATIENT IS UNDERGOING STATURE LENGTHENING WITH RETROGRADE NAILS. IT WAS NOTICED THAT THE CROWN OF BOTH NAILS WERE DISENGAGED WHICH WOULD ALLOW FOR FREE ROTATION OF THE NAIL. AT THIS TIME IT IS UNKNOWN IF A REVISION PROCEDURE HAS BEEN PERFORMED. COMPLAINT 1 OF 2.

  Patient problems: Implant Pain; Metal Related Pathology

  MAUDE report 20361868 ↗
• InjuryMay 22, 2023Corroded; Corroded

  INFORMATION WAS RECEIVED THAT DURING THE PLANNED REMOVAL PROCEDURE METALLOSIS WAS MACROSCOPICALLY DETECTED IN THE REGION OF THE MOST DISTAL LOCKING SCREW AND THERE WAS CONCERN OF POSSIBLE CORROSION.

  Patient problems: Metal Related Pathology

  MAUDE report 16976793 ↗
• InjuryNov 1, 2022Unintended System Motion; Unintended System Motion

  INFORMATION WAS RECEIVED THAT AT A FOLLOW-UP APPOINTMENT, THE REGENERATE WAS NOTICED TO HAVE COLLAPSED BACK TO 16MM. X-RAY IMAGING REVEALED WHAT APPEARED TO BE A CROWN FRACTURE. THE NAIL HAS BEEN EXPLANTED AND EXCHANGED FOR A NEW ONE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15709980 ↗