Optetrak Logic 02-012-44-1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862173461), received between Jul 31, 2023 and Jul 31, 2023 — 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.

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.

• InjuryJul 31, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP LEFT KNEE REPLACEMENT, THIS 67 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED AND USED A REVISION KNEE FROM OTHER COMPANY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN, DISPOSED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17430826 ↗