ATTUNE 2545-01-702Recalls & reported problems
Depuy (Ireland) · ATTUNE TIBIA PREP & IMPACT · Class 1
Quick summary
This DePuy ATTUNE tibia preparation and impact surgical tray is used to prepare the bone during knee replacement surgery. Most of the 46 reports describe the tray's surface coating or paint peeling and delaminating, along with trays cracking, chipping, warping, or wearing down from repeated use and sterilization. No deaths or injuries are reported, and no recalls name this device.
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
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295423522), received between Jul 16, 2020 and May 7, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (31 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/Delaminated31
- Break5
- Naturally Worn5
- Material Twisted/Bent4
- Crack1
- Illegible Information1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient4
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Peeled/Delaminated
IT WAS REPORTED THAT AFTER REPEATED USAGE THE PAN HAD BEGAN PEELING AND WAS NO LONGER UP TO STANDARD FOR THE HOSPITAL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25109677 ↗MalfunctionMar 31, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT IS PEELING FORM TRAYS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744937 ↗MalfunctionMar 13, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY'S PLASTIC COATING IS DELAMINATING. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597852 ↗MalfunctionFeb 2, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TWO ATTUNE PANS ARE PEELING FROM REPEATED USE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24237845 ↗MalfunctionNov 18, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENT TRAY WAS CRACKING DURING THE CLEANING PROCESS. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586446 ↗MalfunctionJul 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENTS WERE PEELING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22398465 ↗MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENTS WERE PEELING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378513 ↗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 21518938 ↗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 21518937 ↗MalfunctionFeb 7, 2025Peeled/Delaminated; Illegible Information; Peeled/Delaminated; Illegible Information
IT WAS REPORTED BY STERILIZATION DEPARTMENT THAT THE PLASTIC ISOLATION IS FALLING OFF OF THE INSTRUMENT TRAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21336526 ↗MalfunctionJan 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074232 ↗MalfunctionJan 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074231 ↗MalfunctionJan 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074230 ↗MalfunctionJan 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074229 ↗MalfunctionJan 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074225 ↗MalfunctionJan 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074222 ↗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 20982044 ↗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 20982040 ↗MalfunctionAug 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INNER BLACK LINING IS PEELING OFF. HOSPITAL WILL NOT STERILIZE TRAY DUE TO THIS REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20007001 ↗MalfunctionJul 1, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19650951 ↗MalfunctionApr 9, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE GRAPHIC CASE FOR INSTRUMENTS IS FLAKING AND PEELING, DEEMING IT CONTAMINATED FOR PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19075723 ↗MalfunctionMar 27, 2024Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material
ADDITIONAL INFORMATION N RECEIVED: A. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. GOUGE IN BLOCK. D. EVENT DESCRIPTION STATES THAT "CUT BLOCK UNABLE TO USE DUE TO SURFACE DAMAGE." PLEASE CLARIFY WHAT YOU MEAN BY DAMAGED. WAS IT BROKE, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? DEEP LACERATIONS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18985636 ↗MalfunctionFeb 1, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT WAS PEELING ON TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18622686 ↗MalfunctionNov 28, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THERE WAS A CHIPPING OF THE TRAY. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18218545 ↗MalfunctionOct 24, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC LININGS OF THE INSTRUMENT TRAYS ARE PEELING AND ARE NO LONGER BEING ACCEPTED BY HOSPITAL STERILE PROCESSING DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995460 ↗
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.