CORAIL L20433Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295258230), received between Aug 18, 2017 and Dec 16, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HEAD WAS UNABLE TO CLIP ON TO THE NECK TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822201 ↗
• MalfunctionNov 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  KHO NECK TRIAL GOT STUCK ON TRIAL BROACH AND WAS DIFFICULT TO REMOVE WHEN TRIALING.THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147709 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085717 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085704 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085579 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085569 ↗
• MalfunctionNov 1, 2022Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THE SPRING IS DAMAGED. THE HEAD WILL NO LONGER ENGAGE ON TRIAL NECK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710973 ↗
• MalfunctionJun 2, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE NECKS REQUIRE REPLACEMENT DUE TO RINGS ON NECK BEING WORN ABS STARTING TO DETACH. NO PATIENT IMPACT. 3 MINUTE DELAY IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 14573782 ↗
• MalfunctionNov 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL CORAIL INSTRUMENTATION IS NOT CONTACTING CORRECTLY. THEY ARE STIFF TO PUT TOGETHER AND ALSO STIFF WHEN REMOVING. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894320 ↗
• MalfunctionOct 19, 2020Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A HEMI HIP ARTHROPLASTY. AFTER TRIALING THE SURGEON PULLED THE TRIALS OUT OF THE PATIENT BUT COULD NOT GET TRIALS TO SEPARATE. THEY WERE USING THE CORAIL SYSTEM WITH THE MOD CATHCART UNIPOLAR/BIPOLAR TRAY. THE NECK TRIALS FROM THE CORAIL SYSTEM KEPT GETTING STUCK ON THE SPACER TRIALS FROM THE MOD CATHCART SYSTEM. THE CASE WAS DELAYED 10 MINUTES TO RETRIEVE ALTERNATE INSTRUMENTS. THE PATIENT WAS NOT HARMED. BOTH INSTRUMENTS ARE BEING RETURNED.

  Patient problems: No Code Available

  MAUDE report 10698131 ↗
• MalfunctionAug 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE "POST" ON CORAIL SZ 14 BROACH APPEARS TO BE SLIGHTLY BENT AND WILL NOT ALLOW TRIAL NECKS TO REST OF THE TRIAL BROACH. KHO CORAIL NECK WILL NOT SEAT PROPERLY ON TRIAL BROACHES. CALCAR PLANAR SHAFT WILL NOT FULLY SLIDE DOWN THE POST ON A TRIAL BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474266 ↗
• MalfunctionJun 9, 2020Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  THE SURGEONS WAS ATTEMPTING TO TRIAL THE HIGH OFFSET NECK TRIAL ON THE SIZE 12 BROACH AS PER NORMAL PROCEDURE, BUT WAS UNABLE TO SEAT THE TRIAL NECK ON THE SIZE 12 BROACH. AFTER BEING UNABLE TO TRIAL THE NECK, THE SURGEON THEN HAD TO IMPLANT THE DEFINITIVE STEM AND THEN TRIAL OFF THAT. UPON INVESTIGATION BY THE TEAM AFTER THE CASE, THEY COULD SEE THAT THE ADAPTOR ON THE BROACH MAY BE DAMAGED PREVENTING THE NECK TRIAL FROM SEATING. THEY ALSO TRIED THE STD NECK TRIAL TO CONFIRM, AND THIS WAS HARD TO SEAT ON THE BROACH TOO. NO REP WAS PRESENT AT THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135642 ↗
• MalfunctionOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DAMAGED INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968865 ↗
• MalfunctionAug 24, 2018Problem with Sterilization; Problem with Sterilization

  SURGEONS FEEDBACK IS HE FEELS THE RUBBER RING WITHIN THE TRIAL NECK SEGMENTS ARE AN INFECTION RISK AND HAS CONCERNS ABOUT THE ABILITY FOR THE PRODUCT TO BE DECONTAMINATED AND STERILISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7814081 ↗
• MalfunctionMar 22, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HIGH OFFSET NECK IS DEFORMED AND WILL NOT ATTACH TO BROACHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363199 ↗
• MalfunctionAug 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RING IN THE HI OFFSET NECK TRIAL WAS PROTRUDING AND NOT LETTING THE FEMORAL HEAD TRIAL SIT ON THE NECK. IT WAS ALSO REPORTED THAT THE PLIERS WERE TRIED TO TAKE OFF AND WAS SQUEEZED BACK IN BUT DIDN'T WORK VERY WELL.

  Patient problems: No Information

  MAUDE report 6805093 ↗