OMEGA 3910500391Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327464795), received between Mar 6, 2019 and Sep 18, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE EYELETS BROKE. THE EYELET CAME OUT AGAIN ON ONE, THE EYELET BROKE ON THE OTHER AND ONLY THE THREAD CAME OUT. THE BROKEN PIECES POTENTIALLY REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360964 ↗
• InjuryDec 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE EYELETS BROKE. THE EYELET CAME OUT AGAIN ON ONE, THE EYELET BROKE ON THE OTHER AND ONLY THE THREAD CAME OUT. THE BROKEN PIECES POTENTIALLY REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360645 ↗
• InjuryAug 25, 2022Material Deformation; Material Deformation

  THE DEVICE WAS RETURNED FOR INVESTIGATION WITH A BROKEN ANCHOR AND THE BROKEN PIECE WAS NOT RETURNED. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION, HOWEVER NO INFORMATION WAS RECEIVED. THEREFORE THIS IS BEING FILED FOR THE ANCHOR POTENTIALLY BREAKING DURING THE PROCEDURE AND POTENTIALLY REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294668 ↗
• MalfunctionAug 24, 2022Material Deformation; Material Deformation

  THE DEVICE WAS RETURNED FOR INVESTIGATION WITH A BROKEN ANCHOR AND THE BROKEN PIECE WAS ALSO RETURNED. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION, HOWEVER NO INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285214 ↗
• MalfunctionAug 4, 2022Break

  IT WAS REPORTED THAT THE EYELET BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163120 ↗
• InjuryNov 22, 2021Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE AND PIECES REMAINED IN THE PATIENT.

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

  MAUDE report 12858279 ↗
• MalfunctionMar 6, 2019Break; Crack

  IT WAS REPORTED THAT THE PRODUCT BROKE. PER ADDITIONAL INFORMATION RECEIVED, THE PRODUCT CRACKED BUT NO BROKEN PIECES SEPARATED FROM THE IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396924 ↗

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-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
• 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