RECLAIM 2976-15-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295156499), received between May 31, 2018 and Aug 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Failure to Cut; Failure to Cut

  DISTAL REAMERS ARE DULL AND NEED REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO PATIENT CONSEQUENCES OR ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163045 ↗
• MalfunctionAug 4, 2022Failure to Cut; Failure to Cut

  DISTAL REAMERS ARE DULL AND NEED REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO PATIENT CONSEQUENCES OR ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163030 ↗
• MalfunctionMay 31, 2018Break; Break

  IT WAS REPORTED THAT THE RECLAIM 15X140 REAMER CONNECTION TIP WAS BROKEN. ALL PIECES WERE REMOVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556400 ↗