OMEGA 3910500472Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327464832), received between Feb 13, 2019 and Oct 15, 2024 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE ARE TWO PATIENTS WITH INFECTION AFTER INSERTION OF THE OMEGA + SPEED ANCHOR.

  Patient problems: Unspecified Infection

  MAUDE report 18784231 ↗
• InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE ARE TWO PATIENTS WITH INFECTION AFTER INSERTION OF THE OMEGA + SPEED ANCHOR.

  Patient problems: Unspecified Infection

  MAUDE report 18784229 ↗
• InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE ARE TWO PATIENTS WITH INFECTION AFTER INSERTION OF THE OMEGA + SPEED ANCHOR.

  Patient problems: Unspecified Infection

  MAUDE report 18778508 ↗
• InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE ARE TWO PATIENTS WITH INFECTION AFTER INSERTION OF THE OMEGA + SPEED ANCHOR.

  Patient problems: Unspecified Infection

  MAUDE report 18778468 ↗
• InjuryFeb 15, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION REQUIRING AN ADDITIONAL PROCEDURE.

  Patient problems: Fungal Infection; Unspecified Infection

  MAUDE report 16382396 ↗
• InjuryFeb 15, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION REQUIRING AN ADDITIONAL PROCEDURE.

  Patient problems: Fungal Infection; Unspecified Infection

  MAUDE report 16382390 ↗
• InjuryOct 13, 2020Material Fragmentation; Material Fragmentation; Device Slipped

  IT WAS REPORTED THAT THE SCREW FELL OFF OF THE INSERTER AND REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10671887 ↗
• InjuryFeb 26, 2020Break; Loose or Intermittent Connection; Break

  IT WAS REPORTED THAT THE ANCHOR REMAINS LOOSE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759524 ↗
• InjuryApr 9, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SCREW BECOME LOOSE IN THE JOINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495598 ↗
• MalfunctionFeb 13, 2019Break

  IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE. THE PROXIMAL FRAGMENT WAS REMOVED AND THE DISTAL FRAGMENT WAS SECURED UNDERNEATH THE REPLACEMENT ANCHOR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8335449 ↗

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 · Terminated
  Stryker, 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 · Terminated
  Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197