ATTUNE 2545-01-704Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIMS & GENERAL INSTRUMENTS · Class 1
Quick summary
This DePuy ATTUNE instrument tray holds surgical shims and general instruments. Most of the 61 reports describe the surface coating peeling or flaking off the trays and inner dividers, with a few mentioning trays breaking, contamination, or bent parts. No deaths or injuries were reported, and reports said there was no patient harm or surgical delay. No recalls name this device, and the number of reports was the same in each of the last two 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295423546), received between Jul 16, 2020 and Apr 6, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (49 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
- Peeled/Delaminated49
- Break6
- Contamination /Decontamination Problem5
- Material Twisted/Bent3
- Illegible Information2
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- Insufficient Information6
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY WAS PEELING APART. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790994 ↗MalfunctionMar 10, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICES ARE DELAMINATING ON THE INNER DIVIDERS, AND PAINT PEELING ON OUTSIDE OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562747 ↗MalfunctionMar 10, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICES ARE DELAMINATING ON THE INNER DIVIDERS AND PAINT PEELING ON OUTSIDE OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562744 ↗MalfunctionMar 10, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICES ARE DELAMINATING ON THE INNER DIVIDERS AND PAINT PEELING ON OUTSIDE OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562733 ↗MalfunctionMar 10, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICES ARE DELAMINATING ON THE INNER DIVIDERS AND PAINT PEELING ON OUTSIDE OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562730 ↗MalfunctionFeb 20, 2026Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED STATING: "IT IS THE LAMINATE ON THE 2 X TRAYS THAT IS PEELING AWAY FROM THE STEEL. BOTH OF THE TRAYS WERE THE SAME. CSD WAS CONCERNED THAT IT WAS ALLOWING POCKETS FOR DEBRIS TO SIT AND THEREFORE CONTAMINATING THE TRAY ."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402606 ↗MalfunctionFeb 20, 2026Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED STATING: "IT IS THE LAMINATE ON THE 2 X TRAYS THAT IS PEELING AWAY FROM THE STEEL. BOTH OF THE TRAYS WERE THE SAME. CSD WAS CONCERNED THAT IT WAS ALLOWING POCKETS FOR DEBRIS TO SIT AND THEREFORE CONTAMINATING THE TRAY ."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402496 ↗MalfunctionJan 27, 2026Peeled/Delaminated
IT WAS REPORTED THAT DURING THE STERILIZATION PROCESS IT WAS OBSERVED THAT THE COLOR FROM THE TRAY CAME OFF. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193433 ↗MalfunctionJan 6, 2026Break; Peeled/Delaminated
IT WAS REPORTED THAT THE SETS ARE PEALING, AND BROKEN INSERTS. IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980933 ↗MalfunctionJan 6, 2026Break; Peeled/Delaminated
IT WAS REPORTED THAT THE SETS ARE PEALING, AND BROKEN INSERTS. IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980921 ↗MalfunctionNov 21, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT WAS FALLING OFF THE PAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616465 ↗MalfunctionMar 21, 2025Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED: TRAYS ARE PEELING PLASTIC AND SPD WILL NOT STERILIZE THE INSTRUMENTS IN THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665768 ↗MalfunctionMar 21, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE SHIMS TRAY WAS PEELING PLASTIC ON AN UNKNOWN DATE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665764 ↗MalfunctionMar 4, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED BY CENTRAL STERILE SERVICES DEPARTMENT (CSSD) THAT THE PLASTIC COATING IS DELAMINATING FROM METAL TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21518954 ↗MalfunctionMar 4, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED BY CENTRAL STERILE SERVICES DEPARTMENT (CSSD) THAT THE PLASTIC COATING IS DELAMINATING FROM METAL TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21518952 ↗MalfunctionMar 4, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED BY CENTRAL STERILE SERVICES DEPARTMENT (CSSD) THAT THE PLASTIC COATING IS DELAMINATING FROM METAL TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21518949 ↗MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ALL TRAYS HAD PLASTIC PEELING OFF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21085886 ↗MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ALL TRAYS HAD PLASTIC PEELING OFF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21085885 ↗MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ON (B)(6) 2024, ALL TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079659 ↗MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ON DECEMBER 16, 2024, ALL TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079650 ↗MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ON DECEMBER 16, 2024, ALL TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079633 ↗MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ON (B)(6) 2024, ALL TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079628 ↗MalfunctionDec 19, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS NOTICED THAT THE PANS WERE DELAMINATING IN SOME PLACES IN THE PAN. THE PLASTIC OR PAINT LAMINATE WAS COMING OFF IN SEVERAL PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20982043 ↗MalfunctionDec 19, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS NOTICED THAT THE PANS WERE DELAMINATING IN SOME PLACES IN THE PAN. THE PLASTIC OR PAINT LAMINATE WAS COMING OFF IN SEVERAL PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20982038 ↗MalfunctionDec 11, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PANS DIDN'T HAVE LABELS ON THEM ANYMORE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20907111 ↗
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
- 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
- Medical Action Industries 6010-1Medical Action Industries Inc. · 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.