Vantage 350-21-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862276223), received between Jun 3, 2019 and May 27, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT DEVELOPED A GANGLION CYST AND BELIEVED THAT THE TIBIAL INSERT WAS DEFECTIVE. AS A RESULT, THE PATIENT UNDERWENT AN ANKLE REVISION APPROXIMATELY, 3 YEARS AND 1 MONTH AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Cyst(s)

  MAUDE report 25307555 ↗
• InjuryJun 6, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE 79 Y/O FEMALE PATIENT HAD A LEFT ANKLE REPLACEMENT ON (B)(6) 2022. APPROXIMATELY 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT ANKLE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT (B)(6) 2022. DIAGNOSIS: LEFT FLATFOOT DEFORMITY. NO COMPLICATIONS DURING THE PROCEDURE AND THE PATIENT WAS STABLE WHEN SENT TO THE PACU.

  Patient problems: Implant Pain

  MAUDE report 17073467 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER A REPORT FROM THE LEGAL DEPARTMENT, A 68 Y/O MALE PATIENT RECIEVED A LEFT ANKLE REPLACEMENT ON (B)(6) 2021. APPROXIMATELY 1 YEARS AND 3 MONTHS POST INITIAL THE PATIENT HAD A LEFT ANKLE REVISION DUE TO PAIN ON (B)(6) 2023. THE IMPLANTS WERE CAREFULLY INSPECTED AND THEY WERE STABLE AND WELL FIXED TO THE SURROUNDING BONE. TRIAL POLYETHYLENE INSERTS WERE UTILIZED TO CONFIRM THAT THE SIZE 2, 8 MM POLYETHYLENE INSERT PROVIDED THE BEST FIT AND STABILITY TO THE ANKLE WITHOUT COMPROMISING MOTION. THE SIZE 8 MM INSERT WAS THEN INSERTED INTO THE TIBIAL COMPONENT AND LOCKED IN PLACE UTILIZING A NEW TIBIAL CLIP. THE WOUNDS WERE CLOSED WITH NYLON SUTURE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 16763462 ↗
• InjuryJun 3, 2019Appropriate Device Problem Term/Code Not Available

  POLY SWAP AND GUTTER DEBRIDEMENT. BONY OVERGROWTH LIMITED ROM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8662927 ↗

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