PRECICE® Intramedullary Limb Lengthening System P10.7-80B245Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812258020255), received between Jan 4, 2021 and Dec 2, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED IN OCTOBER, ON (B)(6) 2025. IT WAS A BILATERAL SURGERY AND TWO NAILS WERE IMPLANTED. ONE WAS WORKING AND THE OTHER WASN'T, SO IN NOVEMBER, ON (B)(6) 2025, SURGERY WAS PERFORMED TO REMOVE THE MALFUNCTIONING NAIL AND IMPLANT ANOTHER. THIS EVENT OCCURRED IN SPAIN.

  Patient problems: Failure of Implant

  MAUDE report 23697362 ↗
• MalfunctionNov 3, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PRECICE NAIL IMPLANTATION WAS ON (B)(6) 2025. AFTER 2 WEEKS THE X-RAYS SHOWED NO MOVEMENT OF THE NAIL. REVISION SURGERY WAS ON (B)(6) 2025. THE NAIL DID NOT TRANSPORT IN SITU BUT DID EX SITU.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457929 ↗
• InjurySep 18, 2024Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20248908 ↗
• InjuryFeb 29, 2024Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT THE NAIL DID NOT LENGTHEN IN THE PATIENT DESPITE USING A DIFFERENT EXTERNAL REMOTE CONTROLLER (ERC). A REVISION PROCEDURE WAS PERFORMED WHERE THE NAIL WAS REMOVED AND TESTED WITH A FAST DISTRACTOR WHICH WAS ABLE TO DISTRACT THE NAIL, HOWEVER, THE SURGEON COULD FEEL IT "CLOCKED IN" THE NAIL. THEREFORE, THE NAIL WAS DEEMED TO BE DAMAGED. THE NAIL WAS EXCHANGED WITH A NEW ONE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18808720 ↗
• MalfunctionSep 26, 2023Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17817556 ↗
• MalfunctionJan 4, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, AFTER ATTACHING THE PRECICE NAIL ONTO THE LOCKING ROD THROUGH THE DRILL GUIDE ARM THE SCRUB NURSE TESTED THE ALIGNMENT OF THE 5MM DRILL INSIDE THE DRILL BUSHING AND DRILL GUIDE AND THE 5MM DRILL WAS NOT ABLE TO GO THROUGH THE SCREW HOLES OF THE NAIL. THIS TEST WAS DONE ON BOTH SCREW HOLES OF THE NAIL. THE SCRUB NURSE THEN UNDID THE ASSEMBLY AND NAIL. THE NAIL WAS AGAIN ATTACHED TO THE LOCKING ROD WITH GUIDE ARM AND THE PROCESS WAS COMPLETED AGAIN YIELDING THE SAME RESULT. THE DRILL COULD NOT GO THROUGH THE SCREW HOLES. THE SURGEON THEN ATTEMPTED THIS PROCESS ALSO WITH THE SAME RESULT. THE NAIL WAS USED IN THE PATIENT WITHOUT DRILLING THROUGH THE GUIDES. THE SURGEON WAS ABLE TO USE THE SAME SCREW HOLES. THE SURGEON COMMENTED THAT THE ALIGNMENT WAS OUT ABOUT 3MM WHICH WAS POSSIBLY THE RESULT OF A BENT DRILL GUIDE ARM OR SCREW HOLES MILLED SLIGHTLY OUT.

  Patient problems: Failure of Implant

  MAUDE report 11115027 ↗