Optetrak Logic 02-012-49-1013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862174222), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K111400); they may or may not involve this specific model.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · 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.

• InjuryMar 17, 2022Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL BRIEF, APPROXIMATELY 5 YEARS POST LEFT TKA, THIS (B)(6) FEMALE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY REVISION FOR PROTHESIS WEAR. THE PATIENT STARTED HAVING PAIN AND ASSOCIATED DYSFUNCTION APPROXIMATELY ABOUT A YEAR AGO AND WORKUP ENSUED AND WAS NEGATIVE FOR INFECTION THROUGH ASPIRIN AS WELL AS LAB WORK, THEN CT SCANS SHOWED SOME LYTIC LESIONS CONCERNING FOR PARTICLE DISEASE. PATIENT WAS REVISED TO COMPETITOR. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13795890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013