Optetrak 244-24-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862064059), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 injury.

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

3 other recalls cover devices cleared under the same FDA submission (K033883); 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, Classified

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

   Z-0019-2022 · 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.

• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT RETURNED TO HOSPITAL FOR INSTABILITY AND PAIN ISSUES. IT WAS NOTED THERE WAS SOME OSTEOLYSIS IN PATELLA AND FEMUR. A REVISION WAS SCHEDULED AND PERFORMED. UPON EXPOSURE AND DEBRIDEMENT, IT WAS NOTED THAT THERE WAS EXTREME BONE LOSS IN ALL COMPARTMENTS FEMUR, PATELLA, AND TIBIA. EVEN WITH THE VERY EXTREME BONE LOSS THE ATTENDING SURGEON DECIDED THE BEST OPTION FOR THIS PATIENT WAS TO ONLY REPLACE THE PATELLA AND INSERT. THE INSERT WAS UPSIZED BY 2MM AND A LARGER PATELLA WAS CEMENTED IN. THE ATTENDING ALSO USED GRAFTON PRODUCTS IN THE BONE VOIDS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL RETAINS ALL RETRIEVALS.

  Patient problems: Osteolysis

  MAUDE report 11367620 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inser
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants