INBONE IB203208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889797048248), received between Oct 16, 2025 and Dec 4, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Positioning Failure; Positioning Failure

  THE POLY TRIALS WOULD DISENGAGE WHEN THE DOCTOR WOULD TRY TO FULLY SEAT THEM INTO THE TIBIAL TRAY DOVE TAILS. ALL PRECAUTIONARY ACTIONS WERE TAKEN TO ENSURE NOTHING WAS IMPEDING THE POLY TRIAL FROM SEATING CORRECTLY. THE PHYSICIAN BELIEVES THE MACHINING OF THE DOVE TAILS ON THE TIBIAL TRAY WERE NOT EVEN ON BOTH SIDES. SPECIFICALLY THE LATERAL SIDE DOVE TAIL WAS MORE PARALLEL (UP AND DOWN) THAN THE MEDIAL SIDE, WHICH SEEMED TO HAVE MORE OF AN ANGLED CUT. FINAL POLY IMPLANT WAS ABLE TO SEAT WITH MINIMAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717263 ↗
• InjuryOct 16, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING AN "INBONE / INVISION SURGERY PLANNED FOR A SZ 3 ON THE TIBIA AND TALAR COMPONENT. SURGEON CHANGED TO A SIZE 2 TALUS INTRAOPERATIVELY. WE DIDN'T HAVE THE SZ 2 PLUS INSERTS AT THE HOSPITAL AND HAD TO CALL THEM IN. SURGEON PROCEEDED TO OPERATE AND TIGHTEN THE LATERAL LIGAMENT'S AND WAS NOTIFIED DURING THAT TIME THAT THE SMALLEST SZ 8 SPACER WAS NOT AVAILABLE IN WA. THE SIZE 10 WAS ON ITS WAY WITH A COURIER, YET HE ADVISED HE WOULD NOT FIT THE 10-INSERT IN. AS THE 8 WAS NOT AVAILABLE HE IMPLANTED THE TRIAL INSERT FROM THE INSTRUMENT SET AND CLOSED THE PATIENT. HE INTENDS TO BRING THEM BACK IN THE REVISE AT A LATER DATE."

  Patient problems: Insufficient Information

  MAUDE report 23317234 ↗