Vantage 350-01-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862276704), received between Aug 8, 2023 and Dec 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCE TALAR SUBSIDENCE. FINDINGS SHOWED LOOSENING OF THE TALAR COMPONENT. AS A RESULT, THE PATIENT WAS REVISED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23840554 ↗
• InjuryAug 8, 2023Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 3 YEARS POSTOP THE INITIAL IMPLANT, THIS 69 YO MALE PATIENT HAD INCREASING DISCOMFORT AND PAIN LOCATED OVER THE SUBTALAR JOINT, ANKLE JOINT, AND ANTEROMEDIAL DISTAL TIBIA. PAIN IS SO SEVERE THAT PATIENT USES BOOT TO AMBULATE. IMAGING DEMONSTRATES FLATTENING OF THE TALAR DOME AND MILD SUBSIDENCE OF THE TALAR HARDWARE AND MULTIFOCAL PERIPROSTHETIC OSTEOLYSIS ALONG THE TIBIAL HARDWARE-BONE INTERFACE MEASURING UP TO 2.1 CM. PATIENT WAS REVISED TO LEFT ANKLE ARTHROPLASTY WITH INBONE-II PROSTHESIS. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. DEVICES WILL NOT BE RETURNED.

  Patient problems: Discomfort; Implant Pain; Osteolysis; Pain

  MAUDE report 17484818 ↗

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