Vantage 351-17-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862532282), received between Jun 29, 2022 and Oct 31, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 18, 2026.

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.

• InjuryOct 31, 2023Break; Break

  AS REPORTED, THE LOANER EQUIPMENT WAS RETURNED TO EXACTECH UK OFFICE AFTER USE DURING SURGICAL PROCEDURE AND REP BECAME AWARE OF THE IMPACTOR BEING BROKEN. THE CASE WAS NOT COVERED BY AN EXACTECH REP,; THEREFORE, SALES REP COULD NOT ASCERTAIN THE EVENTS LEADING UP TO THE BREAKAGE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING EVENT. THE DEVICE WILL BE RETURN. NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044403 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT THE LITTLE BLACK PLASTIC COVER ON THE TOP OF THE IMPACTOR SNAPPED BUT IT WAS STILL HANGING ON SO IN ORDER TO COMPLETE THE SURGERY THEY JUST WRAPPED STERI STRIPS AROUND IT. NO ADVERSE EVENT OR DELAY TO THE SURGERY. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED. UNABLE TO OBTAIN PHOTOS/X-RAYS DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563509 ↗
• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED THAT WHEN USING THE RADEL TIBAL IMPACTOR THE PLASTIC PIECE THAT IS ATTACHED TO THE IMPACTOR BENT AND BROKE OFF. NONE OF THE PLASTIC PIECE ENTERED THE WOUND SITE OR WAS LEFT IN THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. NO INFORMATION OF PRODUCT AVAILABLE FOR RETURN. NO OTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037795 ↗
• InjuryJun 29, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPACTION OF THE CENTER PEG HOLE, THE SURGEON RECOGNIZED A SEVERE FORM OF SCLEROTIC BONE. WHILE PERFORMING THE IMPACTION, THE IMPACTOR TIP OF THE CENTER PEG PUNCH BROKE. WHEN IMPACTING THE FINAL TIBIAL COMPONENT, THIS ISSUES AGAIN OCCURRED AND LED TO A BREAKAGE OF THE TIBIAL RADEL IMPACTOR. THERE WAS A 5-15 MINS SURGICAL DELAY. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859219 ↗

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 Liner Co
• 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