ADVANCE® KFTCNP6RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684KFTCNP6R1), received between Jun 25, 2020 and Mar 3, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P2, MILD DISEASE NOT INCAPACITATING. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11403767 ↗
• InjuryJun 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO STIFFNESS. COMPONENT NOT REVISED: ADVANCE II COCR TIBIA BASE NONPOROUS SZ 6 STANDARD RIGHT PRODUCT ID: KTCCNP60 LOT ID: 301074. REVISION NJR NUMBER: 4394080. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Loss of Range of Motion

  MAUDE report 10196899 ↗