Vantage 350-22-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862293442), received between Apr 24, 2025 and Apr 24, 2025 — 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.

5 other recalls cover devices cleared under the same FDA submission (K152217); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 30, 2021Open, Classified

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

   Z-0024-2022 · Root cause: Process control · 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 24, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ANKLE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A CYST FORMATION, FREQUENT INVERSION EVENTS DUE TO PERSISTENT ANKLE INSTABILITY AND DISCOMFORT WHILE AMBULATING. ENLARGING CYST FORMATION UNDER TIBIA TRAY LEADING TO POTENTIAL SUBSIDENCE. AS A RESULT, APPROXIMATELY 6 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT ANKLE REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Discomfort; Joint Laxity

  MAUDE report 21901994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152217. One submission often covers many models, so check the product and lot details in each record.

• Z-0587-2024 · Nov 21, 2023 · Open, Classified
  Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
• Z-2926-2020 · Aug 10, 2020 · Open, Classified
  The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
• Z-2966-2018 · Jul 13, 2018 · Terminated
  Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
• Z-0200-2018 · May 16, 2017 · Terminated
  Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or dege
• Z-0201-2018 · May 16, 2017 · Terminated
  Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degene