Optetrak 244-24-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862064066), received between Dec 15, 2025 and Dec 17, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Lack of Effect” (1 report).

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

• InjuryDec 17, 2025Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  THE EXPLANTED POLYETHYLENE INSERT DEMONSTRATED MACROSCOPIC WEAR AT THE TIME OF REVISION. REGARDING THE INTRA-OPERATIVE FINDINGS DURING THE REVISION PROCEDURE, NO EVIDENCE OF FEMORAL OR TIBIAL COMPONENT LOOSENING WAS OBSERVED. IN ADDITION, THERE WERE NO FINDINGS SUGGESTIVE OF INFECTION AT THE TIME OF SURGERY. MICROBIOLOGICAL AND HISTOLOGICAL SAMPLES WERE OBTAINED AND, BASED ON THE AVAILABLE RESULTS, NO EVIDENCE OF INFECTION HAS BEEN IDENTIFIED.

  Patient problems: Fall; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Radiolucent Lines; Skin Inflammation/ Irritation; Synovitis

  MAUDE report 23827385 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED SEPTIC ARTHRITIS OF THE RIGHT KNEE TO THE UPPER LIMBS WITH PAIN AND STIFFNESS. THE PATIENT UNDERWENT PERCUTANEOUS TRANSTRACHEAL JET VENTILATION (PTJV) IN 2T REQUIRING DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION (DAIR) POST-OP. THE PATIENT TOOK ANTIBIOTICS TO TREAT THEIR BIOFILM FOR SIX MONTHS AND IT WENT WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 23810944 ↗

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