PRECICE® Intramedullary Limb Lengthening System CPA2-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517001146), received between Feb 24, 2022 and Feb 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

3 FDA recall records name this device's identifier, 3 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-1351-2021 · 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-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.

• MalfunctionFeb 24, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  INFORMATION WAS RECEIVED THAT AFTER A SUCCESSFUL NAIL IMPLANT PROCEDURE, THE PATIENT REPORTED THAT THEY FELT DISCOMFORT AND IT HURT TO FLEX THEIR KNEE. THE SURGEON DETERMINED THAT A REVISION PROCEDURE WOULD BE PERFORMED TO REMOVE THE END CAP THAT WAS PLACED. DURING THE PROCEDURE, THE SURGEON WAS UNSUCCESSFUL IN REMOVING THE END CAP. AT A LATER DATE, A SECOND REVISION PROCEDURE WAS PERFORMED. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE END CAP; HOWEVER, THEY WERE UNSUCCESSFUL. IT WAS THEN DETERMINED THAT THE NAIL WOULD NEED TO BE REMOVED AND REPLACED.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 13595310 ↗