OMEGA 3910500392Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327464801), received between Dec 10, 2021 and Dec 10, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2021Break; Material Fragmentation; Material Fragmentation

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

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

  MAUDE report 12977683 ↗

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