RECLAIM 2976-18-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295156574), received between Sep 5, 2018 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 15162875 ↗
• 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 15162809 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT THE 18X140 RECLAIM REAMER BROKE DURING REAMING. THE METAL AT THE TOP OF CONNECTION BROKE INTO 2 SMALL TABS. ONE TAB WAS FOUND AND WILL BE INCLUDED IN THE SHIPMENT BACK TO THE COMPANY. THE OTHER TAB WAS THROWN AWAY BY MISTAKE AND WAS NOT RETRIEVED IN THE DISPOSABLE SHARPS CONTAINER. THE REAMER WAS NO LONGER USEFUL AS IT WOULD NOT ENGAGED THE REAMER ATTACHMENT APPROPRIATELY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440115 ↗
• MalfunctionSep 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTS TO HIS SALES REPRESENTATIVE ON (B)(6) THAT THEY RECEIVED AN ENTIRE HIP SET WITH RUST ON ALMOST EVERY PART OF THE KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7847056 ↗