Optetrak Unicondylar 252-12-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862065773), received between Feb 5, 2025 and Feb 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0020-2022 · Root cause: Process control · 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.

• InjuryFeb 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL OPERATION. PATIENT STATED THEY UNDERWENT A KNEE REPLACEMENT SURGERY ON THEIR LEFT KNEE, WHICH FAILED, REQUIRING TOTAL KNEE RESTORATION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21314914 ↗