PRECICE® Intramedullary Limb Lengthening System P12.5-80B275Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812258020330), received between Jan 27, 2022 and Dec 16, 2025 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PRECICE HARDWARE EXCHANGE DUE TO A BROKEN NAIL. THE PATIENT REQUIRED AN OSTEOTOMY TO FIX THE MALROTATION OF FEMUR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818463 ↗
• InjuryDec 3, 2024Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT BILATERAL FEMUR LENGTHENING ON (B)(6) 2024. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING A ¿POPPING¿ SENSATION IN THE RIGHT FEMUR DURING ROUTINE PHYSICAL THERAPY. WHILE THE EXACT DATE OF OCCURRENCE IS UNCLEAR, IT IS ESTIMATED TO HAVE TAKEN PLACE WITHIN 7 TO 10 DAYS PRIOR TO (B)(6) 2024. UPON FURTHER EVALUATION USING RADIOGRAPHIC IMAGING, A FRACTURE OF THE FEMORAL NAIL WAS IDENTIFIED. THE PATIENT DENIED ANY HISTORY OF TORSIONAL FORCES OR EXCEEDING PRESCRIBED WEIGHT-BEARING LIMITATIONS. THE REPORTED ¿POPPING¿ WAS ACCOMPANIED BY PAIN AND ROTATIONAL INSTABILITY. ON (B)(6) 2024, THE FRACTURED NAIL WAS SUCCESSFULLY REPLACED, AND THE PATIENT IS NOW SET TO RESUME POST-OPERATIVE LENGTHENING.

  Patient problems: Implant Pain

  MAUDE report 20833101 ↗
• MalfunctionJan 24, 2023Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT WHILE TESTING DURING IMPLANTATION THE NAIL FAILED TO DISTRACT AFTER MULTIPLE ATTEMPTS TO LENGTHEN INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED USING A NEW NAIL. THE NAIL WAS EXAMINED AFTER THE PROCEDURE AND THE MALE/FEMALE JUNCTION WAS REPORTEDLY NEVER SECURELY FASTENED TOGETHER ALLOWING THE NAIL TO BE PULLED APART WITH LITTLE TO NO EFFORT.

  Patient problems: Failure of Implant

  MAUDE report 16234734 ↗
• MalfunctionJan 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING INTEROPERATIVE TESTING PERFORMED AFTER THE NAIL WAS IMPLANTED, THE NAIL FAILED TO LENGTHEN. THE NAIL WAS EXCHANGED WITH ANOTHER NAIL, WHICH LENGTHENED SUCCESSFULLY DURING TESTING. NO PATIENT HARM OR IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367662 ↗