ATTUNE 2545-01-534Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM FEMORAL CUT ASSESSMENT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295457695), received between Mar 18, 2024 and Mar 18, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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
- Contamination /Decontamination Problem4
- Peeled/Delaminated4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT INSTRUMENT TRAYS WERE DAMAGED AND FLAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921235 ↗MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT INSTRUMENT TRAYS WERE DAMAGED AND FLAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921160 ↗MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT INSTRUMENT TRAYS WERE DAMAGED AND FLAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921038 ↗MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT INSTRUMENT TRAYS WERE DAMAGED AND FLAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921011 ↗
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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