Vantage 350-02-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862276742), received between Aug 22, 2023 and Dec 29, 2025 — classified as 3 injuries.

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

6 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2025Migration; Migration

  AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, APPROXIMATELY 2 YEARS AND 5 MONTHS POST THE PATIENT'S PREVIOUS LEFT ANKLE REVISION, THE PATIENT DEVELOPED WORSENING CYST FORMATION AND NEW TALAR SUBSIDENCE. THIS RESULTED IN ANOTHER REVISION TO CORRECT THE TALAR SUBSIDENCE, CYST FORMATION AND OSTEOLYSIS WITH A COMPETITOR IMPLANT. THE OUTCOME IS CONSIDERED TO BE RESOLVED.

  Patient problems: Cyst(s); Osteolysis

  MAUDE report 23906501 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY 3 MONTHS AFTER A RIGHT TSA, THE PATIENT EXPERIENCED POST OPERATIVE NEUROPATHIC PAIN THAT FELT LIKE A CRUSHING OR SQUEEZING AROUND THE ANKLE. THE PATIENT WAS PRESCRIBED MEDICATION AND UNDERWENT NEUROLOGY STUDIES TO RESOLVE THE EVENT AND THE DEVICE REMAINS IMPLANTED. IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE BUT IS RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 19630248 ↗
• InjuryAug 22, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 6 YEARS POSTOP THE INITIAL IMPLANT, THIS 63 YEAR OLD MALE PATIENT WAS REVISED DUE TO A PAINFUL RIGHT TOTAL ANKLE ARTHROPLASTY WITH EVIDENCE OF PROGRESSIVE OSTEOLYTIC BONE CYSTS AROUND THE TIBIAL COMPONENT AND MEDIAL MALLEOLUS. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. DEVICES WILL NOT BE RETURNED.

  Patient problems: Cyst(s); Implant Pain; Osteolysis

  MAUDE report 17595618 ↗

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-0024-2022 · Aug 30, 2021 · Open, Classified
  Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Co
• 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-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
• 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