AS Columbus® CR NN801ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963457020), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 malfunction.

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

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 16, 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.

• MalfunctionMar 10, 2021Component Missing; Component Missing

  IT WAS REPORTED TO AESCULAP AG THAT A COLUMBUS KNEE SYSTEM (PART # N801Z) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, BEFORE UNPACKING THE COLUMBUS AS IMPLANT, A COATING ISSUE WAS OBSERVED. REPORTEDLY, THE CEMENT POCKETS APPEARED TO BE WITHOUT AS COATING. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE CC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456809 ↗