RECLAIM 2975-00-745Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295156123), received between Dec 4, 2019 and May 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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.

• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENTS BROKE DURING EXPLANT. THE PROXIMAL BODY OF RECLAIM WAS COLD WELDED ONTO THE DISTAL STEM. THE DISTAL STEM DID NOT COME OUT. PATIENT WAS NOT HARMED. NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148567 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PUSH ROD TIP WAS BENT, FORCED INTO TRQ SHFT 95, AND NOW STUCK TOGETHER. LOCKING TIP MISSING FROM BODY COLLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779227 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THE HEAD WAS REVISED FOR INFECTION. ATTEMPTS WERE MADE TO REVISE RECLAIM PROXIMAL BUT THE DISASSEMBLY TOOL BROKE IN DIFFERENT PIECES. NO PIECES WERE LEFT IN THE PATIENT. SURGERY TIME WAS EXTENDED FOR 1 HR. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11813789 ↗
• MalfunctionAug 14, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS BROKE WHILE TRYING TO DISENGAGE PROXIMAL BODY. THERE WAS AN (1) ONE HOUR OF SURGICAL DELAY.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10410755 ↗
• MalfunctionDec 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE SCRUB TECH WAS TRYING TO GRIP THE IMPLANT WITH THE DISASSEMBLY TOOL AND THE TOOL WAS NOT GRIPPING (HOLDING ONTO) THE IMPLANT CORRECTLY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 10. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9411713 ↗