Truliant 02-022-35-6012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862304735), received between Apr 21, 2022 and Apr 21, 2022 — 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.

1 other recall 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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

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

   Z-0023-2022 · 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.

• InjuryApr 21, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, THIS MALE PATIENT HAD A KNEE REPLACEMENT SURGERY LAST YEAR. PATIENT HAS DEVELOPED SERIOUS SYMPTOMS SINCE THEN, INCLUDING PAIN, PERSISTENT SWELLING, AND THE KNEE ¿CLICKING.¿ HIS MOBILITY IS NOT GOOD AND IT¿S VERY PAINFUL TO WALK. PATIENT RECEIVED THE RECALL LETTER AND ACTUALLY FELT RELIEVED BECAUSE HE¿S HOPING THAT IT SHOWS THERE¿S A CLEAR ANSWER TO HIS ISSUES. PATIENT HAS NO SCHEDULE REVISION AT THIS TIME. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain; Swelling/ Edema

  MAUDE report 14167778 ↗

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-