RECLAIM 2975-00-675Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295156055), received between Mar 27, 2020 and Apr 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break; Crack

  IT WAS REPORTED THAT THE PROX BODY INSERTER WAS CRACKED IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791652 ↗
• MalfunctionMay 23, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE INSERTER HAS A DENT IN THE PLASTIC SO COULDN'T FIT OVER THE POST. THE METAL POST WAS DENTED AS WELL DIDN'T SLIDE OVER SMOOTHLY.

  Patient problems: Insufficient Information

  MAUDE report 19380509 ↗
• MalfunctionJan 18, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE IMPACTOR COULDN'T SLIDE OVER THE TOP OF THE GUIDE POST. BELIEVE THE PLASTIC HAS WARPED AND NOW NO LONGER WILL ACCOMMODATE IT. WAS ABLE TO GET AWAY WITH IMPACTING IT WITH A NORMAL IMPACT. NO PATIENT IMPACT, NO ADVERSE OUTCOME. SURGERY WAS DELAYED 1 MINUTE DUE TO THE REPORTED EVENT. NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533767 ↗
• MalfunctionJan 18, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TAPER TAMP HAD TROUBLE GOING OVER THE DEPTH GAUGE. SURGEON ASKED TO HAVE IT REPLACED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193614 ↗
• MalfunctionMar 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE OPENING OF TAMP WAS TOO TIGHT TO FIT OVER POST. NO PIECES WAS NOTICED. NO SURGICAL DELAY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889077 ↗