Optetrak Logic 02-012-47-1011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862174147), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K111400); 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.

• InjuryMar 2, 2026Unstable; Naturally Worn

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD A RIGHT TKA, REPORTED EXPERIENCING INTERMITTENT KNEE PAIN, AND NOW IS IN CONSTANT PAIN. SHE WAS SEEN BY HER PCP. SHE NOTED THAT SHE BELIEVED IT WAS A RECALLED POLY IMPLANT. SHE WAS SEEN BY A SURGEON, AND AN X-RAY WAS TAKEN. WEAR AND LOOSENING WERE SEEN. THE PATIENT INDICATED THAT THERE IS PAIN, INSTABILITY, AND LOSS OF MOBILITY. THE SURGEON PRESCRIBED CELECOXIB, AND SHE HAS BEEN SCHEDULED FOR A FUTURE SURGERY. SHE IS CURRENTLY AT HOME WAITING FOR THE SCHEDULED REVISION SURGERY AND REQUIRES THE USE OF A WALKER BECAUSE SHE CAN BARELY WALK. SHE STATED THE X-RAY OF HER KNEE LOOKS LIKE IT IS LEANING TO THE SIDE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 24492311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. 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