ATTUNE 2545-00-469Recalls & reported problems

Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL DRILL PEG TOWER NON-CEMENTED SIZE 9 · 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 10603295433125), received between Jan 10, 2020 and Jan 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

Device Markings/Labelling Problem1
Device-Device Incompatibility1
Inaccurate Information1
Manufacturing, Packaging or Shipping Problem1
No Device Output1

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.

MalfunctionJan 10, 2020No Device Output; Device Markings/Labelling Problem; Device-Device Incompatibility; Manufacturing, Packaging or Shipping Problem; Inaccurate Information; No Device Output; Device Markings/Labelling Problem; Device-Device Incompatibility; Manufacturing, Packaging or Shipping Problem; Inaccurate Information
CEMENTLESS TIBIA PREP TOWER WAS LABELED A 9. DIDN'T FIT ON THE 9 TRAY. ENDED UP FITTING ON A 6.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9574602 ↗

Device details

UDI-DI	`10603295433125`
Brand	ATTUNE
Model	2545-00-469
Catalog no.	254500469
Company	Depuy (Ireland)
Product code	HWT · TEMPLATE
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	Nov 7, 2024

Device type (GMDN): Surgical instrument/implant depth limiter, reusable

A device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Other TEMPLATE devices

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ATTUNE 2545-00-547
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ATTUNE 2544-00-520
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ATTUNE 2545-00-545
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ARTICUL/EZE 2530-91-000
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All TEMPLATE 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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