Vantage 350-22-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862276384), received between Sep 8, 2022 and Nov 4, 2024 — classified as 2 injuries.

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.

• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 2 YEARS, 1 MONTH, 22 DAYS POST-OPERATIVE OF A RIGHT TAA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A CYST FORMATION. X-RAYS SHOW A NEW CYST APPROXIMATELY 11 X 9 MM. FOLLOWING, ANOTHER SURGEON DETERMINED SURGICAL INTERVENTION WAS BEST TO RESOLVE THIS. THEY DECIDED THAT REMOVING THE POLY, DEBRIDING THE GUTTERS, BACK FILLING THE BONE CYST WITH BONE GRAFT, AND THEN INSERTING A NEW POLY COMPONENT. THE PATIENT UNDERWENT REVISION SURGERY WITH THE REPORTED REMOVAL OF THE TIBIAL INSERT. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Cyst(s)

  MAUDE report 20604462 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH VANTAGE TOTAL ANKLE STUDY, THAT A 57 YO MALE PATIENT, WHO HAD AN INITIAL ANKLE IMPLANTED ON (B)(6) 2017, REPORTED PAIN ALONG THE MEDIAL ASPECT OF THE ANKLE AND THE LATER ASPECT OF THE ANKLE, JUST IN THE SUB-FIBULAR AREA, ALONG THE POSTERIOR TIBIAL TENDON, AND HE REPORTED DIFFICULTY WALKING. DATE OF ADVERSE EVENT ONSET, (B)(6) 2022. HE WAS GIVEN A SUPINATOR BRACE AND A CORTICOSTEROID SHOT INTO THE SUBTALAR JOINT. UNLIKELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME INDICATES CONTINUING. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15385691 ↗

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-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
• 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