PRECICE® Bone Transport System BT10-90X340-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517979742), received between Mar 11, 2024 and Mar 11, 2024 — classified as 1 injury.

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. 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 ↗

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-1324-2021 · 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.

• InjuryMar 11, 2024Break; Break

  INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED WITH PAIN IN THE KNEE. X-RAY EXAMINATION REPORTEDLY REVEALED THE IMPLANT WAS FRACTURED. PER THE REPORTER, THE PATIENT DID NOT REGULARLY ATTEND THE SCHEDULED X-RAY EXAMINATIONS TO CHECK, THEREFORE, THE DOCKING SITE AND PSEUDOATRHROSIS COULD NOT BE CHECKED BY THE PHYSICIAN FOR A LONG TIME. THE PATIENT DENIED HAVING HAD ANY FALLS. A REVISION PROCEDURE WAS PERFORMED AND THE NAIL WAS EXPLANTED. THE PATIENT WAS REPORTED TO HAVE BEEN FULL WEIGHT BEARING BEYOND THE INSTRUCTIONS FOR USE (IFU). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18880613 ↗