ATTUNE 2504-40-604Recalls & reported problems

Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION CONVENTIONAL CUT GUIDE SIZE 4 · Class 1

All models of ATTUNE (1475)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295438434), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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.

Most reported problems

Device problems

Entrapment of Device1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 15, 2018Entrapment of Device; Entrapment of Device
DURING SURGERY PIN SEIZED IN CUTTING BLOCK, WHEN ATTEMPTING TO REMOVE IT FROM THE BLOCK, THE PIN BROKE IN HALF. HALF REMAINS IN THE CUTTING BLOCK AND THE OTHER HALF REMAINS IN THE POWER PIN DRIVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7966863 ↗

Device details

UDI-DI	`10603295438434`
Brand	ATTUNE
Model	2504-40-604
Catalog no.	250440604
Company	Depuy (Ireland)
Product code	HTZ · INSTRUMENT, CUTTING, ORTHOPEDIC
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Other INSTRUMENT, CUTTING, ORTHOPEDIC devices

SIGMA LCS 9505-01-230
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95 reports
ATTUNE 2544-00-522
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
58 reports
SIGMA LCS 9505-01-229
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
56 reports
SIGMA 2024-40-100
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
43 reports
ATTUNE 2545-00-158
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
41 reports
ATTUNE 2545-00-156
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
41 reports
SIGMA 2024-40-200
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
40 reports
ATTUNE 2545-00-155
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
39 reports

All INSTRUMENT, CUTTING, ORTHOPEDIC devices →

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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