ATTUNE INTUITION 2545-07-700Recalls & reported problems
Depuy (Ireland) · ATTUNE INTUITION ESSENTIAL CEMENTED GENERAL INSTRUMENTS · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10603295537427), received between May 28, 2026 and Jun 2, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (8 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Peeled/Delaminated
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE STERILE PROCESSING DEPARTMENT (SPD) WAS REQUIRING THESE WORN TRAYS BE REPLACED WITH NEW TRAY DUE TO WORN OUT PLASTIC COMING OFF THE TRAY. THERE WERE NO DELAYS AND NOTHING LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364687 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313504 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313494 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313493 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313491 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313489 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313486 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313281 ↗
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
- Calibrate CLCCXSIMPAAlphatec Spine, 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
- n.a. 39501A2Karl Storz GmbH & Co. KG · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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