Optetrak Logic 02-012-65-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862265890), received between Dec 26, 2019 and Aug 28, 2024 — 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.

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

• InjuryAug 28, 2024Mechanical Problem; Lack of Effect; Mechanical Problem; Lack of Effect

  AS REPORTED, APPROXIMATELY ONE YEAR AGO THE PATIENT WAS REVISED FROM COMPETITOR DEVICES TO A CCK. RECENTLY, THE PATIENT CAME IN STIFF, SO WAS DOWNSIZED FROM A 15 CCK INSERT TO A 9 CCK INSERT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 20086018 ↗
• InjuryDec 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED THIS 64 Y/O FEMALE¿S RIGHT KNEE WAS INITIALLY IMPLANTED DURING A RTK PROCEDURE ON (B)(6) 2010. THE PATIENT WAS REVISED FOR AN INFECTION OVER A YEAR AGO AND HAS BEEN EXPERIENCING VERY LIMITED RANGE OF MOTION AND HAD ROUGHLY A 20-DEGREE FLEXION CONTRACTURE AND BARELY 30 DEGREES OF FLEXION. THE SURGERY OPERATED NOT SURE WHAT THE ISSUE WAS BUT WAS THINKING POOR PHYSICAL THERAPY WHICH RESULTED IN SIGNIFICANT SCAR TISSUE. AS WAS EXPECTED, THERE WAS A LOT OF SCAR TISSUE REMOVED AND A LARGER CCK INSERT WAS USED (FROM A 15MM TO A 17MM). SURGEON WAS THRILLED ABOUT THE RANGE OF MOTION ACHIEVED POST-OPERATIVELY. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE RANGE OF MOTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED SINCE THE DEVICES WERE NOT RETURNED; HOWEVER, IT IS MOST LIKELY IS RELATED TO PATIENT CONDITIONS.

  Patient problems: Failure of Implant

  MAUDE report 9519536 ↗

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