PRECICE® Bone Transport System BT10-80D320-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517980205), received between Dec 22, 2025 and Dec 22, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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. Feb 12, 2021Class IIOpen, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1324-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 12, 2021Class IIOpen, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1323-2021 · Root cause: Under Investigation by firm · 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.

• MalfunctionDec 22, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT ANKLE ARTHRODESIS, AND A BONE TRANSPORT FEMUR NAIL, PREVIOUSLY PLANNED BY THE SURGEON, WAS IMPLANTED. DURING POSTOPERATIVE FOLLOW-UP, IT WAS OBSERVED THAT THE IMPLANT WAS NOT FUNCTIONING. A NEW SURGERY WAS SCHEDULED FOR (B)(6) 2025. THE IMPLANT WAS CHECKED BOTH INSIDE AND OUTSIDE THE PATIENT USING A FAST DISTRACTOR AND WITH ERC (ELECTROMAGNETIC RESONANCE IMAGING), AND THE MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. THEREFORE, IT WAS DECIDED TO REPLACE IT WITH A NEW ONE, WHICH ULTIMATELY DID FUNCTION. THE DELAY IN REPORTING THE INCIDENT WAS DUE TO THE HOSPITAL FIRST DECONTAMINATING THE NAIL, AND THEN SEVERAL INTERNAL COMMUNICATION ERRORS (AN INTERNAL NON-CONFORMITY REPORT HAS BEEN FILED REGARDING THIS ISSUE, AND TRAINING WILL BE PROVIDED).

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

  MAUDE report 23865365 ↗