Vantage 350-21-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862276216), received between Aug 31, 2023 and Mar 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

5 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0024-2022 · Root cause: Process control · FDA record ↗

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.

• InjuryMar 9, 2026Naturally Worn

  THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL ANKLE ARTHROPLASTY. THE PATIENT LATER PRESENTED TO THE SURGEON¿S OFFICE WITH PAIN AND POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 24547012 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT ANKLE REPLACEMENT ON (B)(6) 2019 DUE TO END-STAGE ARTHRITIS, LEFT ANKLE, AND CYSTIC FORMATION, LEFT TALUS. THEY UNDERWENT LEFT ANKLE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 3 YEARS 1 MONTH POST PRIMARY PROCEDURE. IN REVISION OP REPORT, THE SURGEON NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF SCAR TISSUE FORMATION AT THE ANTERIOR ASPECT OF THE ANKLE JOINT WITH SIGNIFICANT INVAGINATION INTO THE JOINT AND MEDIAL AND LATERAL ANKLE GUTTERS. THERE WAS SMALL BONE GROWTH OVER THE ANTERIOR ASPECT OF THE TIBIAL TRAY. THERE IS SIGNIFICANT AMOUNT OF FIBROTIC SCAR TISSUE NOTED ALONG THE MEDIAL AND LATERAL ASPECTS OF THE ANKLE JOINT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 17663653 ↗

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-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