Optetrak Logic 02-012-35-1509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862180759), received between Mar 13, 2023 and Sep 15, 2025 — classified as 2 injuries.

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 (K093360); 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.

• InjurySep 15, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL TOTAL KNEE REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED; REASON UNKNOWN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23057273 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 78 YO FEMALE PATIENT HAD AN INFECTION. ON (B)(6) 2022, SHE WENT TO THE ICUS DUE TO PAIN IN HER RIGHT KNEE, FUNCTIONAL LIMITATION AND THAT ON EXAMINATION REDNESS AND SUPPURATION OF MATERIAL FROM THE PROXIMAL PART OF THE HERDIA (WOUND) WAS EVIDENCED, A CURE WAS PERFORMED, AND SAMPLES WERE TAKEN FOR CULTURE. ON (B)(6) 2022, SURGICAL DEBRIDEMENT AND NEW SAMPLING FOR CULTURE WAS CARRIED OUT. DEBRIDEMENT IS REPEATED ON (B)(6) 2022, PERFORMING DAIR ((DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) WITH CHANGE OF MOVING PARTS. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICE AND UNLIKELY RELATED TO PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 16527321 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ