Optetrak Logic 02-012-39-3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862002679), received between Sep 16, 2019 and Sep 16, 2019 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K932776); 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.

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.

• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS MALE PATIENT EXPERIENCED A RIGHT TKA ON (B)(6) 2012. A PENDING REVISION WAS REPORTED. THE REASON FOR THE REVISION WAS NOT REPORTED. NO OTHER INFORMATION REPORTED. THE REASON FOR THE PENDING REVISION REPORTED WAS NOT PROVIDED BUT WAS LIKELY THE RESULT OF WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, OR PATIENT RELATED FACTORS.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9069820 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING