CORAIL 2665-99-000Recalls & reported problems
Depuy Orthopaedics, Inc. · CORAIL AMT CASE COMPLETE · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295150015), received between Jul 1, 2020 and May 6, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Reports received per month
Most reported problems
Device problems
- Break6
- Naturally Worn6
- Peeled/Delaminated5
- Crack4
- Detachment of Device or Device Component2
- Material Deformation1
Patient problems
- Insufficient Information3
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Break; Crack; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENT WAS CRACKED/BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092491 ↗MalfunctionFeb 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC PARTS OF TRAY WERE CRACKED AND BREAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257592 ↗MalfunctionOct 18, 2024Break; Crack; Peeled/Delaminated; Naturally Worn; Break; Crack; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. THE LIDS AND INSERT WERE ALL CRACKED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20480873 ↗MalfunctionOct 18, 2024Crack; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Naturally Worn; Crack; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Naturally Worn
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. THE LIDS AND INSERT WERE ALL CRACKED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20480871 ↗MalfunctionOct 18, 2024Break; Crack; Peeled/Delaminated; Detachment of Device or Device Component; Naturally Worn; Break; Crack; Peeled/Delaminated; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024 . THE LIDS AND INSERT WERE ALL CRACKED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20480869 ↗MalfunctionJul 1, 2020Break; Naturally Worn; Break; Naturally Worn
UPON INSPECTION, STAFF NOTICED SEVERE WEAR OF TRAYS INCLUDING PAINT FLAKING OFF OF METAL INSERTS. HOSPITAL IS WORRIED ABOUT TRAYS CREATING DEBRIS IN THE TRAY WRAPPERS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10221189 ↗MalfunctionJul 1, 2020Break; Naturally Worn; Break; Naturally Worn
UPON INSPECTION, STAFF NOTICED SEVERE WEAR OF TRAYS INCLUDING PAINT FLAKING OFF OF METAL INSERTS. HOSPITAL IS WORRIED ABOUT TRAYS CREATING DEBRIS IN THE TRAY WRAPPERS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10221188 ↗MalfunctionJul 1, 2020Break; Naturally Worn; Break; Naturally Worn
UPON INSPECTION, STAFF NOTICED SEVERE WEAR OF TRAYS INCLUDING PAINT FLAKING OFF OF METAL INSERTS. HOSPITAL IS WORRIED ABOUT TRAYS CREATING DEBRIS IN THE TRAY WRAPPERS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10221187 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- INSTRUMENT 6541-9-109Howmedica Osteonics Corp. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 11580AKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.