Optetrak Logic 02-012-42-5008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862003447), received between Nov 12, 2020 and Nov 12, 2020 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K071738); 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.

• InjuryNov 12, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2012. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10833460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071738. One submission often covers many models, so check the product and lot details in each record.

• Z-0953-2013 · Feb 1, 2013 · Terminated
  Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
• Z-2234-2012 · Oct 17, 2011 · Terminated
  OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The