OMEGA 3910500471Recalls & reported problems
Stryker Corporation · Omega 4.75mm PEEK Knotless Anchor System, Single · Class 2 · Implant
All models of OMEGA (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Omega knotless anchor is a soft-tissue fixation anchor used in shoulder and other arthroscopy procedures to secure sutures. The 31 reports mostly describe the anchor or its eyelet breaking during insertion or use, sometimes leaving fragments in the patient, plus anchors coming apart or coming loose, and a few cases where it was used past its expiration date. Eight reports describe injuries and no deaths were reported. Reports fell from 5 in the earlier12 months to 2 in the most recent 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327464818), received between Feb 13, 2019 and Aug 28, 2026 — classified as 8 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Break” (18 reports).
2 other recalls cover devices cleared under the same FDA submission (K181083, K202355); they may or may not involve this specific model.
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
- Break18
- Material Fragmentation9
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Expiration Date Error2
- Entrapment of Device1
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Foreign Body In Patient6
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 25 most recent of 31 reports, 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 ↗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 ↗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 ↗MalfunctionNov 30, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242823 ↗MalfunctionJul 25, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17393484 ↗MalfunctionMay 1, 2023Break; Break
IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16845874 ↗MalfunctionFeb 15, 2023Break
IT WAS REPORTED THAT THE EYELET BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16382169 ↗MalfunctionJan 4, 2023Break
I WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16098923 ↗MalfunctionJan 4, 2023Break
I WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16098920 ↗MalfunctionNov 29, 2022Break; Break
IT WAS REPORTED THAT THE EYELET BREAKAGE OCCURRED IN THE JOINT AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15879584 ↗MalfunctionNov 17, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SCREW DISENGAGED OFF OF THE INSERTER DURING THE PROCEDURE AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15816337 ↗MalfunctionNov 11, 2022Break; Material Disintegration; Material Disintegration
IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE AND ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15784730 ↗InjuryAug 10, 2022Break
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE. THE BROKEN SCREW REMAINS IN THE PATIENT'S BONE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15201169 ↗MalfunctionApr 20, 2021Break; Entrapment of Device
PLEASE NOTE THAT THE INITIAL REPORT'S TYPE OF REPORTABLE EVENT WAS SERIOUS INJURY, BUT THROUGH THE INVESTIGATION IT WAS CONFIRMED THAT THE BROKEN PIECES DID NOT REMAIN IN THE PATIENT. THEREFORE MAKING THIS EVENT A MALFUNCTION.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 11694925 ↗InjuryApr 13, 2021Break; Break
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND REMAINS IN THE PATIENT. NOTE, THE PIECE OF THE BROKEN SCREW THAT REMAINS IN THE PATIENT IS SECURELY IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11655696 ↗InjuryMar 31, 2021Break; Break
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND REMAINS IN THE PATIENT. NOTE, THE PIECE OF THE BROKEN SCREW THAT REMAINS IN THE PATIENT IS SECURELY IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11597369 ↗InjuryMar 29, 2021Break; Break
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND REMAINS IN THE PATIENT. NOTE, THE PIECE OF THE BROKEN SCREW THAT REMAINS IN THE PATIENT IS SECURELY IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11586767 ↗InjuryMar 26, 2021Break
PLEASE NOTE THAT THE INITIAL REPORT'S TYPE OF REPORTABLE EVENT WAS SERIOUS INJURY; PER ADDITIONAL INFORMATION RECEIVED, THE EVENT DESCRIPTION MOST LIKELY INDICATES SCREW ADVANCEMENT FORCE TOO LARGE, SCREW PLUNGES. THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY THEREFORE MAKING THIS EVENT NOT REPORTABLE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11575045 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K181083, K202355. One submission often covers many models, so check the product and lot details in each record.
- Z-1148-2020 · Jul 19, 2019 · TerminatedStryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
- Z-1147-2020 · Jul 19, 2019 · TerminatedStryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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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