Vantage 350-10-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862302021), received between Feb 5, 2025 and Aug 13, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 16, 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.

• InjuryAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 72 YO MALE PATIENT, WHO HAD THEIR LEFT ANKLE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE TIBIAL CLIP WAS FOUND ON A LATERAL X-RAY TO BE COMING OUT OF THE POLY. THE POLY WAS EXCHANGED WITH A NEW TIBIAL CLIP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS

  Patient problems: Insufficient Information

  MAUDE report 22801004 ↗
• InjuryAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 72 YO MALE PATIENT, WHO HAD THEIR LEFT ANKLE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE TIBIAL CLIP WAS FOUND ON A LATERAL X-RAY TO BE COMING OUT OF THE POLY. THE POLY WAS EXCHANGED WITH A NEW TIBIAL CLIP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS.

  Patient problems: Insufficient Information

  MAUDE report 22800987 ↗
• InjuryFeb 5, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY 27 MONTHS AFTER A LEFT TOTAL ANKLE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PAIN AND AMBULATION DIFFICULTIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology; Pain

  MAUDE report 21312503 ↗

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