SIGMA 9505-02-903Recalls & reported problems
Depuy (Ireland) · SIGMA 150 MACRO CASE · Class 1
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295230014), received between Jan 22, 2019 and Jan 22, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (3 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.
Most reported problems
Device problems
- Peeled/Delaminated3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE CR150 TRAY WAS PEELING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8268851 ↗MalfunctionJan 22, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE CR150 TRAY WAS PEELING. PLEASE SEND REPLACEMENT SOS TO WNC OFFICE. NO ADDITIONAL INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8268830 ↗MalfunctionJan 22, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE CR150 TRAY WAS PEELING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8268780 ↗
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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