Omega 3910947204Recalls & reported problems
Stryker Corporation · 3.9MM OMEGA DRILL · Class 1
All models of OMEGA (7)
Data updated Oct 18, 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 07613327550078), received between Apr 2, 2024 and Aug 22, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (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
- Expiration Date Error2
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT THE REP OPENED AN EXPIRED DRILL BIT AND PUT IT IN THE INSTRUMENT PAN AND HAD IT STERILIZED FOR A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877143 ↗MalfunctionAug 22, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT THE REP OPENED AN EXPIRED DRILL BIT AND PUT IT IN THE INSTRUMENT PAN AND HAD IT STERILIZED FOR A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877117 ↗MalfunctionApr 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19028851 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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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