Vantage 350-22-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862276339), received between Dec 20, 2022 and May 17, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

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.

• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 37 MONTHS AFTER A RIGHT TOTAL ANKLE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Pain

  MAUDE report 19341474 ↗
• InjuryApr 25, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A RIGHT ANKLE REPLACEMENT PROCEDURE ON (B)(6) 2019 AND THEN WAS REVISED ON (B)(6) 2024. THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

  Patient problems: Cyst(s); Failure of Implant; Scar Tissue

  MAUDE report 19182308 ↗
• InjuryDec 20, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL THAT A 59 YO FEMALE PATIENT HAD AN RIGHT ANKLE REVISION PROCEDURE ON (B)(6) 2021 AND HAD A SECOND REVISION ON (B)(6) 2022. REVISION WAS NOTED TO BE FOR FLEXOR DIGITORUM LONGUS TEAR; MEDIAL GUTTER IMPINGEMENT; PERIPROSTHETIC CYST AT THE TALAR COMPONENT; INSTABILITY; DIFFICULTY GETTING TO NEUTRAL DORSIFLEXION; DIFFICULTY WALKING AND WEIGHT-BEARING; STIFFNESS, LOSS OF MOVEMENT AND FLEXIBILITY; PAIN AT THE POSTERIOR ASPECT, TIGHTNESS IN THE POSTERIOR ASPECT; SWELLING OF THE ANKLE. CURRENT REPORTED CONDITION OF PATIENT-RIGHT ANKLE PAIN AND LOSS OF RANGE OF MOTION, NON-WEIGHT BEARING, USE OF CRUTCHES, PAIN MEDICATION, BACK AND NECK PAIN DUE TO ABNORMAL GAIT. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 16016689 ↗

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