RECLAIM 2976-21-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295156710), received between Sep 10, 2018 and Oct 10, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2018Corroded; Corroded

  RUST ON INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951403 ↗
• 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). THIS KIT WENT TO CUSTOMER ON (B)(6) 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 DECEMBER (B)(6) THIS YEAR. IMPACTED PRODUCTS WILL BE FILLED IN WHEN WE WILL RECEIVED THE KIT BACK ON ST PRIEST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859815 ↗