Optetrak Logic 02-012-65-4019Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862266156), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K150890); 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.

• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY ONE-MONTH POST LTKA, THE PATIENT ON (B)(6) 2020 CLINIC VISIT, SUBJECT PRESENTED WITH A HEMATOMA ON HIS LEFT TKA, AND WAS PLACED IN A KNEE IMMOBILIZER. AT (B)(6) 2020 VISIT, SUBJECT HAD INCREASED DRAINAGE AND WAS SCHEDULED FOR A REVISION ON (B)(6) 2020 WITH I&D. THIS PATIENT HAS A HISTORY OF INFECTION IN THIS KNEE. THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. INFORMATION RECEIVED FROM CLINICAL STUDY DATABASE. THE DEVICE WILL NOT RETURN DUE TO CLINICAL STUDY POLICY. OUTCOME WAS REPORTED AS RESOLVED. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection; Hematoma

  MAUDE report 12584241 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150890. 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
• Z-1364-2020 · Jan 27, 2020 · Open, Classified
  Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, s
• Z-3209-2018 · May 8, 2018 · Open, Classified
  Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total k
• Z-2704-2017 · Apr 7, 2017 · Terminated
  Exactech Optetrak Logic CC 15mm Tibial Augment Screws