OMEGARecalls & reported problems across all models
Stryker Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 7 models of OMEGA by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Feb 13, 2019 and Aug 28, 2026 — classified as 22 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
- Break24
- Material Fragmentation14
- Expiration Date Error6
- Patient Device Interaction Problem4
- Delivered as Unsterile Product2
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Foreign Body In Patient9
- No Known Impact Or Consequence To Patient6
- Unspecified Infection6
- Device Embedded In Tissue or Plaque3
- Insufficient Information3
- Fungal Infection2
OMEGA models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OMEGA 3910500471Fastener, fixation, nondegradable, soft tissue31 reports
- OMEGA 3910500472Fastener, fixation, nondegradable, soft tissue11 reports
- OMEGA 3910500391Fastener, fixation, nondegradable, soft tissue8 reports
- Omega 3910947204BIT, DRILL3 reports
- 2 reports
- OMEGA 3910500392Fastener, fixation, nondegradable, soft tissue1 report
- OMEGA 3910500652Fastener, fixation, nondegradable, soft tissue1 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.
MalfunctionAug 28, 2026Expiration Date Error
It was reported that the item was used post expiration in a case.
Patient problems: Insufficient Information
MAUDE report 50488534 ↗MalfunctionMar 2, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY AND PERFORMING A BICEPS TENODESIS, THE APPROPRIATE SUTURES WERE PASSED THROUGH THE BICEPS AND WE WERE GOING TO FIX IT WITH AN OMEGA ANCHOR. THE SUTURE WAS THREADED THROUGH THE PEEK TIP OF THE OMEGA, THE ANCHOR WAS IMPACTED, AND WHEN THE HANDLE WAS REMOVED AND TRACTION WAS APPLIED TO THE SUTURES TO ALLOW THE PEEK TIP TO HORIZONTALIZE, THE PEEK CAME OUT AND WAS FOUND TO BE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24491523 ↗MalfunctionSep 23, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT THE ITEM WAS USED 2 DAYS POST EXPIRATION IN A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23127368 ↗MalfunctionSep 18, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED IMPLANT WAS IMPLANTED IN A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23091613 ↗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 ↗MalfunctionJun 19, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR TIP BROKE OFF WHEN HAMMERING IN. PER ADDITIONAL INFORMATION RECEIVED, ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292831 ↗MalfunctionMay 20, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT OMEGA EYELET BROKE WHILE INSERTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22057474 ↗MalfunctionFeb 13, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21381233 ↗MalfunctionNov 8, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644064 ↗InjuryOct 18, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE PEEK KNOTLESS ANCHOR SYSTEM BROKE DURING SURGERY. THE SCREW POTENTIALLY BROKE DURING THE PROCEDURE AND THE PIECES WERE POTENTIALLY NOT ABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 20487734 ↗MalfunctionOct 17, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20474427 ↗MalfunctionOct 15, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457512 ↗MalfunctionMay 22, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SCREW BROKE AND CAME OUT WITH INSERTER WHEN THE INSERTER WAS PULLED OUT. BROKEN PIECES REMAINED IN PATIENT BODY.
Patient problems: Foreign Body In Patient
MAUDE report 19378273 ↗MalfunctionMay 22, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19378251 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
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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