RECLAIM 2976-14-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295156475), received between Aug 28, 2018 and Nov 10, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THE REAMER IS DULL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775669 ↗
• 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 15163024 ↗
• 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 15162829 ↗
• MalfunctionSep 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE 14 MM REAMER IS CROSS THREADED AT THE TOP THREADS AND THE MARKINGS FOR THE SIZE ARE UNABLE TO BE READ ANYMORE. NOT USED IN A CASE SO NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554389 ↗
• 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 10685748 ↗
• MalfunctionOct 12, 2020Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO PIECES BROKE OFF FROM THE INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10667189 ↗
• MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM 14X140MM REAMERS IS NOT CONNECTING TO THE REAMER SHAFT PROPERLY AND NEEDS TO BE REPLACED. THE REAMERS LOCKS TO THE REAMERS SHAFT BUT IS LOOSES AND WOLVES AROUND. THIS PART NEED TO BE REPLACED AND IS BEING SENT BACK TO DEPUY. NO PARTS BROKE OFF THE INSTRUMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775450 ↗
• MalfunctionAug 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RECLAIM 14X140 REAMER WAS MALFUNCTIONING AND NOT ATTACHING PROPERLY TO THE REAMER GUIDE. IT NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7823930 ↗