Truliant, Activit-E 02-024-35-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862597168), received between Jan 21, 2026 and Jan 21, 2026 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K223252); 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 16, 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.

• InjuryJan 21, 2026Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY. AS A RESULT, THE SURGEON DID A POLY SWAP AND INCREASED THE POLY THICKNESS TO A 4X11MM PS POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 24130000 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223252. One submission often covers many models, so check the product and lot details in each record.

• Z-0586-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515,