EIT CIF cage CUI8060LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557770658), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 20, 2022Open, Classified

   Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

   Z-1323-2022 · Root cause: Labeling Change Control · FDA record ↗

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.

• MalfunctionMar 17, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SALES REPRESENTATIVE WAS HANDING THE NURSE A 6MM CONDUIT CAGE. WHEN THE BOX WAS OPENED, A SIZE 7 WAS IN THE BOX. THE OUTSIDE OF THE BOX SHOWS A 6MM AND THE GRAFT, INSIDE THE BOX, WAS A 7MM. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNEVENTFUL AND PROGRESSING AS EXPECTED. THIS REPORT INVOLVES ONE (1) EIT CIF CAGE, H 6MM, 8°, L. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791353 ↗