NA 02-029-11-8000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862523006), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K170240, K171045, K181794); 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.

• MalfunctionMar 15, 2022Break; Break

  AS REPORTED, DURING SURGICAL USE, THE PIN BECAME LODGED IN THE CUTTING BLOCK AND BROKE OFF IN THE PIN REMOVER AS WELL. THERE WAS NO BREAKAGE OF A DEVICE. PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. THE SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772221 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170240, K171045, K181794. 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