ATTUNE 2545-01-703Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL SIZING & FINISH · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE femoral sizing and finishing tray is a surgical instrument tray and case used to hold and size hip replacement components. Most of the 64 reports describe the plastic lining or paint peeling and delaminating from the tray surfaces after repeated use and cleaning, with a few reports of broken or bent instruments. No deaths or injuries are reported. 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
- 62
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295423539), received between Aug 22, 2018 and May 26, 2026 — classified as 62 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (52 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated52
- Contamination /Decontamination Problem5
- Break4
- Material Twisted/Bent3
- Naturally Worn3
- Illegible Information2
- No Apparent Adverse Event2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient7
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026No Apparent Adverse Event
IT WAS REPORTED THE INSTRUMENT HAD UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276783 ↗MalfunctionApr 29, 2026Peeled/Delaminated
IT AS REPORTED THAT THE INSTRUMENT BOX HAD LOOSENED LAMINATION. NO IMPACT ON PATIENT FLOW, OR IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031495 ↗MalfunctionApr 11, 2026Peeled/Delaminated
IT WAS REPORTED THAT WHEN CLEANING AN ATTUNE CASE IT WAS OBSERVED THAT THE CASE HAD A SPLIT IN THE LAMINATION, AND STERILITY COULD NOT BE GUARANTEED. NO IMPACT ON SURGERY TIME. NO PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850617 ↗MalfunctionApr 3, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT ON EXTERIOR OF TRAY PEELING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774595 ↗MalfunctionFeb 27, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE PRODUCT HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474696 ↗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 24237800 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY WAS DELAMINATING AND THE HOSPITAL WAS ASKING FOR IT TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220870 ↗MalfunctionDec 17, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS EXHIBITED PEELING PAINT AND DELAMINATION ON THE INSIDE. NO PATIENT INVOLVEMENT OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830521 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643212 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643211 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643209 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643208 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643198 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643197 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643196 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643190 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643189 ↗MalfunctionNov 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS BLACK COVERINGS WERE PEELING, HOSPITAL REQUESTING NEW TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643186 ↗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 22398464 ↗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 21518953 ↗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 21518946 ↗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 21336513 ↗MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL WAS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303136 ↗MalfunctionJan 7, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ALL TRAYS HAD PLASTIC PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21091639 ↗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 21085694 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- n.a. 39501XKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Calibrate CLCCXOIMPAAlphatec Spine, Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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