LCS 2267-31-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295108801), received between Aug 7, 2019 and Aug 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

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.

• MalfunctionAug 7, 2019Break; Device-Device Incompatibility; Material Twisted/Bent; Break; Device-Device Incompatibility; Material Twisted/Bent

  12.5 MM SHIM ISN'T ATTACHING TO THE SPACER HANDLE. IT FELL OFF DURING THE CASE AND A NEW TRAY NEEDED TO BE OPENED. IT WAS TESTED ON A DIFFERENT HANDLE AND CONTINUED TO BE LOOSE AND FALL OFF. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5 MINS. ACTION TAKEN WHEN EVENT OCCURRED? A NEW INSTRUMENT SET WAS OPENED. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO.

  Patient problems: Not Applicable

  MAUDE report 8869659 ↗