PRECICE® Intramedullary Limb Lengthening System LSC5-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812258021627), received between Dec 2, 2022 and Aug 3, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

4 FDA recall records name this device's identifier, 4 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 ↗

3. 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-1351-2021 · Root cause: Device Design · Recall details · FDA record ↗

4. 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-1350-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT DURING A CONSULT, A LOCKING BOLT WAS EVIDENT THROUGH THE SKIN. A REVISION PROCEDURE WAS PERFORMED WHERE THEY REARRANGED THE BOLT. AS PER THE REPORTER, THE PATIENT HAS POOR BONE QUALITY WHICH MAY HAVE CONTRIBUTED TO THE PULL OUT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17451628 ↗
• MalfunctionDec 2, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT ONE OF THE LOCKING SCREWS IN THE IMPLANTED NAIL BACKED OUT. THE PATIENT WAS INSTRUCTED TO CONTINUE LENGTHENING AND LATER DURING A CLINIC THE SCREW WAS NOTED TO BE COMPLETELY BACKED OUT. A REVISION PROCEDURE IS PLANNED ON AN UNKNOWN DATE TO RE-ADJUST THE SCREW. THE PATIENT WAS REPORTED TO HAVE PRESENTED WITH PAIN ADJACENT TO THE BACKED OUT SCREW.

  Patient problems: Pain

  MAUDE report 15906945 ↗