ATTUNE 2545-01-707Recalls & reported problems
Depuy (Ireland) · ATTUNE CR TRIALS SIZE 3-8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 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 10603295423577), received between Feb 14, 2020 and Nov 17, 2023 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated8
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2023Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED. INDICATES, THAT THE EVENT WAS DETECTED AFTER A ROUTINE RE-PROCESSING PROCEDURE. AND DID NOT OCCUR, DURING A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18160708 ↗MalfunctionNov 16, 2023Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? -NO PATIENT CONSEQUENCES. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? -YES. 2 MINUTE DELAY. C. PLEASE CONFIRM IF THERE WAS ANY ALLEGED DEVICE DEFICIENCY REPORTED FOR THE 254501707 (ATTUNE CR TRIALS SZ 3-8)? -PAINT CHIPPING. UNABLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156727 ↗MalfunctionMay 11, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT IS FLAKING CAUSING POSSIBLE CONTAMINATION.
Patient problems: Insufficient Information
MAUDE report 16915690 ↗MalfunctionMay 11, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT IS FLAKING CAUSING POSSIBLE CONTAMINATION.
Patient problems: Insufficient Information
MAUDE report 16913546 ↗MalfunctionMay 10, 2023Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING A SURGERY BUT THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16905343 ↗MalfunctionMay 10, 2023Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING A SURGERY BUT THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16905135 ↗MalfunctionDec 7, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE CUSTOMER IS COMPLAINING THE ATT-CONTAINERS AS CONTAINER´S PLASTIC COATING IS LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15931975 ↗MalfunctionFeb 14, 2020Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INSTRUMENT CASES WERE REPORTED BY SPD BECAUSE THE PLASTIC COATING IS PEELING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9714708 ↗
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
- 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
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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