CORAIL L98516Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295262640), received between Jul 21, 2017 and Feb 17, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 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.

• MalfunctionFeb 17, 2026Material Deformation

  IT WAS REPORTED THAT THE TRIAL WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363646 ↗
• MalfunctionDec 13, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT TWO TRIAL CORAIL REVISION STEMS DEFORMED DURING SURGERY. THE DISTAL SPLINES WERE BENT. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20928806 ↗
• MalfunctionJul 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SALES REP REPORTS THAT DURING A REVISION SURGERY, THE SURGEON HAD A PROBLEM ON HIS ANCILLARY CORAIL REVISION ON DEPOSIT, ON THE TRIAL STEM SIZE 16. THE SURGEON HAD A VERY ODD FEEL AND TRYING A CORAIL STEM OF THE SAME SIZE, IT TURNED OUT THAT THE METAPHYSEAL FILLING WAS NOT IDENTICAL. HE ALSO COMPARED THE TRIAL STEM SIZE 16 WITH AN OTHER TRIAL STEM SIZE 16 FROM A LOAN KIT. THEY DID NOT HAVE THE SAME DIMENSIONS.

  Patient problems: No Information

  MAUDE report 6732322 ↗