RECLAIM 2976-20-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295156659), received between Jul 21, 2017 and Sep 10, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionSep 10, 2018Corroded; Corroded

  CUSTOMER REPORTS THAT THEY RECEIVED A SECOND ENTIRE HIP SET WITH RUST ON ALMOST EVERY PART OF THE KIT ON (B)(6) (THIS 2ND KIT WAS SENT TO REPLACE THE FIRST ONE SENT ON AND RECEIVED ON (B)(6) (SEE (B)(4)). THIS KIT WENT TO CUSTOMER ON OCTOBER 11TH, 2017 AND WAS NEW AT THE TIME (1ST USE), IT CAME BACK TO (B)(4) AND WAS CHECKED ON OCTOBER 19TH 2017. THEN IT GOES TO CUSTOMER ON (B)(6) THIS YEAR. IMPACTED PRODUCTS WILL BE FILLED IN WHEN WE WILL RECEIVED THE KIT BACK ON (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859532 ↗
• 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 7847188 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT THE CUTTING FLUTES ON RECLAIM REVISION REAMERS HAVE CHIPS ON THEM.

  Patient problems: No Information

  MAUDE report 6731256 ↗