Truliant 02-020-13-0245Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862320650), received between Apr 6, 2022 and Apr 6, 2022 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K171045); 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.

• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY THREE MONTHS POST INITIAL RTKA, THIS (B)(6) FEMALE PATIENT'S KNEE WAS STILL STIFF. SURGEON DID CLOSED MANIPULATION NINETEEN DAYS LATER AND PATIENT WILL FOLLOW UP WITH PHYSICAL THERAPY. PER CLINICAL STUDY THIS EVENT IS NOT RELATED TO THE DEVICE BUT DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 14027558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-
• Z-0023-2022 · Aug 30, 2021 · Open, Classified
  TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR