PRECICE® Intramedullary Limb Lengthening System P8.5-50C195Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812258020378), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE NAIL WAS REMOVED BECAUSE THE SCHEDULED LENGTH HAD BEEN ACHIEVED. A CRACK IN THE NAIL WAS NOT NOTICED UNTIL IT WAS OUT OF THE PATIENT AND ON THE BACK TABLE. X-RAY IMAGES REVEALED "A SCREW" STILL IN TIBIAL CANAL. AFTER EXAMINING THE NAIL, THE ANTI-ROTATION LUG WAS NOT IN THE NAIL BUT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13695206 ↗