ADVANCE® KFTCNN2LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684KFTCNN2L1), received between Oct 9, 2020 and Feb 10, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Packaging Problem; Packaging Problem

  ALLEGEDLY, DURING A PATIENT OPERATION TODAY: (B)(6), THE DOCTOR AND OUR MEDICAL REPRESENTATIVE IDENTIFIED THE MISMATCH AFTER THE PATIENT HAD ALREADY BEEN PREPPED FOR SURGERY. THIS REQUIRED OUR TEAM TO URGENTLY REPLACE THE ITEM TO PROCEED WITH THE OPERATION, CAUSING DELAYS AND SIGNIFICANT INCONVENIENCE. PRODUCT DETAILS: 1. ITEM AND BATCH DETAILS OUTSIDE THE BOX: CODE: KFTCNN2L. LOT#: 17552492028826. 2. ACTUAL ITEM INSIDE THE BOX: (B)(6). ADDITIONAL INFORMATION RECEIVED: DELAY GREATER THAN 30 MINUTES WHILE PATIENT WAS IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21343708 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(6). SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11404510 ↗
• InjuryOct 9, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR , ASEPTIC LOOSENING TIBIA , LYSIS FEMUR AND LYSIS TIBIA. REVISION NJR NUMBER: (B)(4), SIDE:L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Osteolysis

  MAUDE report 10658276 ↗