OMEGARecalls & reported problems across all models
Stryker GmbH · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 20 models of OMEGA by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2015 and Jun 4, 2025 — classified as 11 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Break” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OMEGA problems
Device problems
- Break25
- Fracture25
- Material Deformation8
- Mechanics Altered5
- Loose or Intermittent Connection4
- Difficult to Insert3
- Bent2
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient39
- No Clinical Signs, Symptoms or Conditions14
- Injury4
- Insufficient Information4
- Device Embedded In Tissue or Plaque3
- Failure of Implant3
- Foreign Body In Patient3
- Bone Fracture(s)2
OMEGA models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OMEGA 704001ORTHOPEDIC MANUAL SURGICAL INSTRUMENT14 reports
- OMEGA 704005ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- OMEGA 704004ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- OMEGA 3362-5-095APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- OMEGA 3362-5-105APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT5 reports
- OMEGA 3362-5-110APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT5 reports
- OMEGA 3362-5-100APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- OMEGA 704013ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- OMEGA 704009ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- OMEGA 597024SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- OMEGA 3362-5-090APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- OMEGA 704002ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- OMEGA 704011SORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- OMEGA 704014ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- OMEGA 597012SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- OMEGA 597032SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- OMEGA 597144SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- OMEGA 704047ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- OMEGA 597404SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- OMEGA 3362-5-115APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
Recent OMEGA adverse event reports
The 15 most recent reports across all models, 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 ↗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 22141606 ↗MalfunctionSep 19, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A BROKEN PLATE WAS FOUND IN THE QUEENSLAND KIT ROOM. UPDATE: IT WAS CONFIRMED BY EVALUATION OF THE DEVICE THAT THE DEVICE HAD BEEN IMPLANTED AND BROKE IN THE PATIENT AND WAS REVISED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17777823 ↗MalfunctionApr 14, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A CONNECTING BOLT FROM AN OMEGA 3 DHS KIT WAS BROKEN. THE DEVICE WAS DISCARDED BY THE CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 16742743 ↗MalfunctionMar 21, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DEVICE BROKE.
Patient problems: Insufficient Information
MAUDE report 16582166 ↗MalfunctionJan 23, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED: "THE SURGEON WAS USING THE IMPACTOR TO IMPACT A SIDE PLATE ONTO A LAG SCREW. ON IMPACTION, THE HANDLE CRACKED AND BROKE IN 2 PIECES. ALL DEBRIS REMOVED-LARGE PIECES." ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN. NO ADDITIONAL MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16229265 ↗MalfunctionDec 6, 2022Material Deformation; Material Deformation
AS REPORTED: "OMEGA LAG SCREW TABS DEFORMED AS LAG SCREW WAS BEING INSERTED INTO PATIENT. HAD TO REMOVE & PUT IN A SHORTER SCREW. SURGEON TAPPED BEFORE INSERTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15925087 ↗InjuryNov 10, 2022Break; Fracture; Break; Fracture
AS REPORTED: "THE PATIENT HAD A SECOND REVISION OF HIP FRACTURE WITH STRYKER'S OMEGA 3 PLATE. HER PRIMARY SURGERY WAS A NAIL AND HER FIRST REVISION SURGERY WAS A STRYKER OMEGA 3 PLATE ALSO. UPON REMOVING THE OMEGA 3 PLATE TO PUT ANOTHER ONE IN, THE SURGEON NOTICED AN UNUSUAL BREAK. HE BELIEVED THAT THIS COULD POTENTIALLY BE DUE TO A FAULTY PLATE AND ASKED FOR IT TO BE STUDIED IN THE LAB."
Patient problems: Failure of Implant
MAUDE report 15769512 ↗MalfunctionFeb 14, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTED A FOREIGN BODY IN AN OMEGA IMPLANT BOX.
Patient problems: Insufficient Information
MAUDE report 13524633 ↗MalfunctionDec 28, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT WHEN THE NURSE OPEN THE STERILE PACK, THEY FOUND THE INSECT IN THE STERILE PACK. THEY REPLACED TO THE NEW ONE AND CONTINUED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13102199 ↗MalfunctionDec 17, 2021Break; Break
THE CUSTOMER REPORTED THAT THE IMPACTOR BROKE. NO DEBRIS WERE LEFT IN THE PATIENT'S BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13031663 ↗MalfunctionAug 26, 2021Fracture; Fracture
IT WAS REPORTED "THE THREAD OF THE INNER PART BROKE OFF INTRAOPERATIVELY. REPLACEMENT WAS AVAILABLE. A SURGICAL DELAY OF 1 MINUTE WAS REPORTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12369743 ↗MalfunctionAug 19, 2021Material Deformation; Material Deformation
IT WAS REPORTED THE OPERATING TEAM HEARD A "CRUNCH" AND NOTICED THE LABS ON THE OMEGA LAG SCREW HAD DEFORMED DURING INSERTION. SURGEON TOOK SCREW OUT AND PUT A NEW ONE IN. THE SCREW WAS NOT BENT PRIOR TO INSERTION. ONE STEP INSERTION WRENCH WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12345040 ↗MalfunctionMay 17, 2021Mechanics Altered; Mechanics Altered
THE CUSTOMER REPORTED THAT THE TRIPLE BARRELED REAMER WHICH SHOULD FIX IN SITU BECAME LOSE WHILE REAMING AND THE WIRE IT WAS REAMING OVER BECAME STUCK AND HAD TO BE REMOVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11836388 ↗MalfunctionApr 2, 2021Break; Break
AS REPORTED: "OMEGA 3 PLATE IMPACTOR FAILED DURING IMPACTION OF PLATE. IT HAS FAILED BY WAY OF BREAKAGE JUST BELOW HOLES OF THE PLASTIC SECTION ABOVE WHERE IT SCREWS INTO THE METAL IMPACTOR, THIS WAS DURING ITS USE TO SEAT THE PLATE ON THE BONE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11608918 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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