RECLAIM 2976-13-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295156468), received between Oct 15, 2020 and Aug 21, 2024 — 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 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE NEW START REAMER IS DULL.

  Patient problems: Insufficient Information

  MAUDE report 20014642 ↗
• MalfunctionJun 16, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  TWO OF THE PARTS FOR THE RECLAIM CONSIGNMENT SET ON SHELF ARE TIRED AND NEED REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011672 ↗
• MalfunctionOct 15, 2020Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO CONSEQUENCE OF DELAY, THE DELAY WAS ABOUT 5 MINUTES TRYING TO GET THE REAMERS TO ENTER THE CANAL.

  Patient problems: No Code Available

  MAUDE report 10685804 ↗