CORAIL L20502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295258650), received between Feb 4, 2022 and Sep 8, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 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 8, 2023Break; Corroded; Contamination /Decontamination Problem; Break; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT INSERT IS DETERIORATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711023 ↗
• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATED THE FOLLOWING: 1. QUANTITY RETURNED - ALL KITS RETURNED TO JOHNSON 2. CLEANING SOLUTION AND PROCESS - THESE DIRT ARE IDENTIFIED AT THE TIME OF OPENING THE MATERIAL FOR SURGERY. WE ARE WAITING FOR YOUR RESPONSE TO FORWARD A SOLUTION BECAUSE THE STAINS ON THE KITS DO NOT WASH OFF. WE JUST ADVISE YOU TO FOLLOW THE PRODUCT'S IFU. 3. CLARIFICATION ON WHAT PARTS WERE INVOLVED SINCE THE PHOTOS SHOW ONLY THE TRAYS WITH THE FOREIGN MATERIAL. - THE PARTS THAT WE REPORTED IN THE COMPLAINT (STEMS) THAT SHOW SOOT AND CAUSE THESE STAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454690 ↗
• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PROSTHESES / INSTRUMENTS FROM THE DPS JOINTS FRANCHISE ARE SHOWING (COMING OUT) SOOT AFTER THE STERILIZATION PROCESS AND THAT THE BOXES ALSO HAVE DARK SPOTS ON THE TRAYS WHICH, ACCORDING TO THE HOSPITAL, REPRESENTS THAT THE MATERIAL IS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454123 ↗