LinkSymphoKnee - Instruments 881-509/00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575310203), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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. Jun 27, 2024Open, Classified

   The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.

   Z-2445-2024 · Root cause: Process 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.

• MalfunctionJun 28, 2024Inaccurate Information; Inaccurate Information

  FOR PROF. (B)(6), THE PATELLA SELECTED WITH THE SIZING TEMPLATE APPEARED TOO LARGE. A REMEASUREMENT OF THE SIZING TEMPLATE HAS OBVIOUSLY RESULTED IN A REVERSED LABELING ON THE SIZING TEMPLATE. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631399 ↗