Optetrak Logic 02-012-65-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862266002), received between Jun 7, 2022 and Jun 7, 2022 — 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.

• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL RIGHT TKA, SURGEON PREFORMED A POLY SWAP TO THE (B)(6) FEMALE PATIENT DUE TO INSTABILITY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14622959 ↗

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