Truliant 02-022-44-4511Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862305374), received between Aug 12, 2020 and Aug 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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.

• InjuryAug 12, 2020Unstable; Unstable

  ON (B)(6) 2018, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 35.9, UNDERWENT IMPLANTATION OF A INSERT TIBIAL TRULIANT PSC SZ4.5 11MM. ON (B)(6) 2019, APPROXIMATELY 11 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY.

  Patient problems: Failure of Implant

  MAUDE report 10399262 ↗

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-