PRECICE® Intramedullary Limb Lengthening System P10.7-80D275Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812258020651), received between Sep 14, 2016 and May 18, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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.

• MalfunctionMay 18, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT HAD A LEFT FEMORAL LENGTHENING PROCEDURE WHERE 8 CM LENGTHENING WAS PLANNED VIA NUVASIVE PRECICE MAGNETIC NAIL WHICH WAS PLANNED. AFTER BRIEFLY GAPPING 5 MM, NAIL FAILED TO LENGTHEN AND DETERMINED TO BE DEVICE FAILURE. A REVISION SURGERY PERFORMED WITH NEW NAIL PLACED.

  Patient problems: Failure of Implant

  MAUDE report 25204460 ↗
• MalfunctionAug 25, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PRECICE NAIL WAS UNABLE TO BE DISTRACTED INTRA-OPERATIVELY, IT WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883201 ↗
• InjurySep 14, 2016Device Operates Differently Than Expected

  A DISTRIBUTOR REPORTED THAT A PATIENT'S PRECICE NAIL WAS REMOVED AFTER APPROXIMATELY ONE (1) MONTH OF IMPLANTATION. THE SURGEON ALLEGED THAT THE NAIL DID NOT APPEAR TO HAVE ACHIEVED EXPECTED TARGET LENGTH.

  Patient problems: No Code Available

  MAUDE report 5950514 ↗