PRECICE® Intramedullary Limb Lengthening System P10.7-50D230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812258020637), received between Jun 22, 2022 and Jul 1, 2022 — classified as 2 injuries.

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

• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED WITH NON-UNION OF THE OSTEOTOMY AND LENGTHENING SITE AND SEVERE MUSCLE ATROPHY. THE NAIL REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 14889870 ↗
• InjuryJun 22, 2022Break; Break

  INFORMATION WAS RECEIVED THAT THE RIGHT SIDE NAIL BROKE WHILE THE PATIENT WAS WALKING. THE PATIENT VISITED THE HOSPITAL PRESENTING WITH PAIN AND WAS UNABLE TO WALK. THE NAIL HAS BEEN EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 14775295 ↗