S-ROM NOILES 2178-01-105Recalls & reported problems
Depuy (Ireland) · S-ROM NOILES HINGE FEMORAL PREP SET · Class 1
All models of S-ROM NOILES (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295093718), received between Mar 8, 2021 and Jun 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (2 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/Delaminated2
- Contamination /Decontamination Problem1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Naturally Worn; Peeled/Delaminated; Contamination /Decontamination Problem; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT TRAYS ARE FLAKING AND PEELING. THERE WERE NO AFFECTS TO THE PATIENTS AND NO SURGERY DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583069 ↗MalfunctionMar 8, 2021Peeled/Delaminated; Peeled/Delaminated
DURING THE CONTROL OF THE KIT FZG858NS4, IT WAS DISCOVERED THAT THE FLOCKING WAS GOING AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11438903 ↗
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- 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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