PRECICE® Intramedullary Limb Lengthening System P8.5-80B275Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812258020224), received between Nov 25, 2020 and Nov 6, 2023 — classified as 1 injury, 4 malfunctions.

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.

• MalfunctionNov 6, 2023Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT THE NAIL DID NOT LENGTHEN INTRA-OPERATIVELY AND WAS SWAPPED OUT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18075176 ↗
• MalfunctionDec 9, 2021Material Twisted/Bent; Material Twisted/Bent

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Implant Pain

  MAUDE report 12970788 ↗
• MalfunctionDec 9, 2021Break; Break

  N/A.

  Patient problems: Implant Pain

  MAUDE report 12969673 ↗
• InjuryJun 9, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021 DUE TO A BENDING NAIL ON LEFT LEG. THE PATIENT WAS REPORTED TO BE IN BED ALL THE TIME AFTER THE INITIAL IMPLANT SURGERY BUT FELT SOMETHING WAS WRONG. THE PATIENT OUTCOME WAS REPORTED AS HEALTHY.

  Patient problems: Failure of Implant

  MAUDE report 11970113 ↗
• MalfunctionNov 25, 2020Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO PAIN. AS PER THE REPORTER, X-RAY IMAGES REVEALED THAT THE NAIL WAS BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 10901790 ↗