Vantage 350-11-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862276148), received between Sep 13, 2022 and Jul 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Structural Problem” (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 16, 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.

• InjuryJul 14, 2025Structural Problem; Structural Problem

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST OP INITIAL LEFT ANKLE REPLACEMENT, THIS 56 Y/O FEMALE PATIENT WAS REVISED DUE THE LOCKING CLIP DISASSOCIATED FROM TIBIAL TRAY. CLIP BROKE IN SITU. SURGEON SWAPPED OUT CLIP & POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO IMAGES OR X-RAYS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22500178 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL ANKLE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY (B)(6) 2021 THE PATIENT DEVELOPED A CYSTIC FORMATION ON THE TIBIAL AND TALAR SIDE. THE COMPONENTS ARE NOT LOOSE AND NO FAILURE OF IMPLANT DETECTED. ALIGNMENT IS WELL MAINTAINED, BUT PAIN PERSISTS AND IT IS DIFFICULT TO WALK. THE PATIENT WAS REVISED ON (B)(6) 2022.

  Patient problems: Cyst(s); Failure of Implant; Pain

  MAUDE report 15414813 ↗

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 Line
• 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