RECLAIM 2976-16-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295156512), received between Dec 4, 2017 and Aug 4, 2022 — classified as 4 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 4 most recent of 4 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 15163062 ↗
• 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 15163060 ↗
• MalfunctionMar 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED AS " REFER HAS THE THREADED REFER REMOVAL COLD WELDED TOGETHER." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452975 ↗
• MalfunctionDec 4, 2017Break; Break

  IT WAS REPORTED THAT THE CONNECTION PART OF RECLAIM 16 X 140 REAMER IS BROKEN AND NEEDS TO BE REPLACED. IT WOULD NOT CONNECT TO THE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7080249 ↗