OMEGA 704014Recalls & reported problems
Stryker GmbH · Variable Angle Guide · Class 1
All models of OMEGA (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540451200), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2025Break; Fracture; Break; Fracture
AS REPORTED: "WE HAVE HAD AN OMEGA 2 GUIDE FOR 135 PLATES 704013 BREAK DURING USE AND PART OF THE INSTRUMENTS HAS GOTTEN STUCK INSIDE THE PATIENT, [...] WE HAVE ALSO NOTICED THAT THE SMALL METAL INSERT IS ALSO ON THE VARIABLE ANGLE GUIDE 704014."
Patient problems: Foreign Body In Patient
MAUDE report 22141610 ↗
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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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