Vantage 351-10-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862318015), received between Dec 16, 2022 and Oct 4, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 4, 2024Fracture; Fracture

  AS REPORTED, WHILE USING THE CENTRAL HOLE PUNCH ON THE MODULAR IMPACTOR HANDLE, IT SNAPPED JUST ABOVE WHERE IT INSERTS INTO THE MODULAR HANDLE. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS A 5-15 MINUTE DELAY TO SURGERY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. THIS EVENT IS NOT ASSOCIATED WITH A REVISION OF EXACTECH IMPLANTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369512 ↗
• MalfunctionDec 16, 2022Break; Break

  AS REPORTED, THE IMPACTOR HANDLE BROKE DURING USE. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT OR THE WOUND SITE. THE REPORTED EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996027 ↗

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