BioAVS UniLIF IS2640BPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327141979), received between May 25, 2016 and Jun 16, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

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.

• MalfunctionJun 16, 2016Break

  IT WAS REPORTED THAT; ONE OF THE TINES ON THE BONE INSERTER BROKE OFF. THE FACILITY HAD TWO INSERTERS. THEY WERE ABLE TO USE THE SECOND INSERTER TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5730877 ↗
• MalfunctionMay 25, 2016Break; Mechanical Problem; Mechanical Jam; Mechanical Problem

  IT WAS REPORTED THAT; INSERTED JAMMED THEN BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5680258 ↗