OMEGA 3362-5-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327092905), received between Sep 20, 2019 and Sep 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 other recall cover devices cleared under the same FDA submission (K955306); 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.

• MalfunctionSep 20, 2019Difficult to Insert; Positioning Problem; Difficult to Insert

  AS REPORTED: "COMPRESSION SCREW WOULD NOT ENTER LAG SCREW. A NEW LAG SCREW WAS USED." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SOME SURGICAL DELAY BUT NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9099824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955306. One submission often covers many models, so check the product and lot details in each record.

• Z-1865-2008 · Jan 25, 2005 · Terminated
  Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plate