Vantage 351-07-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862563415), received between Nov 18, 2020 and May 17, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Break; Fracture; Break; Fracture

  AS REPORTED, WHILE IMPACTING THE TALAR COMPONENT, THE ARMS ON THE PLASTIC PART OF THE TALAR IMPACTOR SNAPPED OFF AND THE PROTECTOR FELL OFF. THE SURGEON REMOVED ALL PARTS/PIECES FROM THE PATIENT. THERE WAS A SURGICAL DELAY OF <5 MINUTES; NO ADVERSE EVENTS AS A RESULT. THIS EVENT IS NOT ASSOCIATED WITH A REVISION OF EXACTECH PRODUCTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341699 ↗
• MalfunctionSep 25, 2023Break; Break

  AS REPORTED, DURING PROCEDURE WHILE IMPACTING THE TALUS THE BLACK PLASTIC IMPACTOR BROKE. THERE WERE NO PARTS, PIECES OR FRAGMENTS FELL INTO PATIENT WOUND SITE AND THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. PRODUCT WILL BE RETURN. AS OF NOTE: "BY THE LOOK OF THE X-RAYS THE FINAL TALUS IMPACTION PROBABLY ISN¿T ACHIEVED BUT WILL BE ONCE THE PATIENT IS FULLY WEIGHT BEARING". NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814911 ↗
• MalfunctionMay 27, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPACTION OF THEN TALAR IMPLANT, THE TALAR IMPLANT INSERTER BROKE. NO PARTS OR PIECES FELL INTO THE PATIENTS WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521104 ↗
• MalfunctionMay 10, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPACTION OF THE TALAR IMPLANT, THE TALAR IMPLANT INSERTER BROKE. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETUNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345250 ↗
• InjuryApr 19, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPACTION, THE JOINT WAS VERY STIFF AND THE SURGEON HAD TO HIT THE TALAR IMPACTOR VERY HARD TO PUSH THE FINAL IMPLANT IN. WHEN THE FIRST TALAR IMPACTOR PLASTIC PROTECTION BROKE, WE HAD ANOTHER ON THAT WAS ONSITE TO USE BUT IT BROKE AS WELL. AFTER REMOVING THE BROKEN PIECE AND CLEANING OUT THE PATIENT, WE COULD STILL USE THE TALAR IMPACTOR PLASTIC PROTECTION TO COMPLETE THE SURGERY WITH NO FURTHER COMPLICATIONS. THERE WAS A SMALL SURGICAL DELAY THAT WAS LESS THAN 5 MINUTES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT AS A RESULT OF THE SURGICAL DELAY/ PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140501 ↗
• InjuryApr 19, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPACTION, THE JOINT WAS VERY STIFF AND THE SURGEON HAD TO HIT THE TALAR IMPACTOR VERY HARD TO PUSH THE FINAL IMPLANT IN. WHEN THE FIRST TALAR IMPACTOR PLASTIC PROTECTION BROKE, WE HAD ANOTHER ON THAT WAS ON SITE TO USE BUT IT BROKE AS WELL. AFTER REMOVING THE BROKEN PIECE AND CLEANING OUT THE PATIENT, WE COULD STILL USE THE TALAR IMPACTOR PLASTIC PROTECTION TO COMPLETE THE SURGERY WITH NO FURTHER COMPLICATIONS. THERE WAS A SMALL SURGICAL DELAY THAT WAS LESS THAN 5 MINUTES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140496 ↗
• MalfunctionApr 6, 2022Break; Break

  AS REPORTED, DURING IMPACTION OF THEN TALAR IMPLANT, THE TALAR INSERTER BROKE. NO PARTS OR PIECES FELL INTO THE PATIENTS WOUND SITE. NO SURGICAL DELAY PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14023303 ↗
• MalfunctionApr 5, 2022Break; Break

  SURGEON WAS IMPACTING THE TALUS AND WHEN HE WENT TO MALLET, THE BLACK TIP OF THE TALUS IMPACTOR BROKE OFF. THE TINY PIECE THAT BROKE OFF THE TIP WAS DISCARDED IN THE OR BUT I WAS ABLE TO KEEP THE MAIN PORTION OF THE BLACK TIP OFF THE TALUS IMPACTOR. PATIENT WAS NOT AFFECTED BY THIS. PATIENT NOT AFFECTED BY THIS. THERE WAS NO SURGICAL DELAY/PROLONGATION. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14012946 ↗
• MalfunctionDec 1, 2021Break; Break

  AS REPORTED, DURING SURGERY/IMPACT, THE SURGEON USED THE TALAR IMPACTOR AS RECOMMENDED AND REALIZED THE INSERT BROKE AT ONE OF THE SIDES WHILE IMPACTING FINAL TALAR IMPLANT. NO OTHER PATIENT INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913502 ↗
• MalfunctionNov 18, 2020Break; Break

  WHILE IMPACTING THE TALUS IMPLANT THE PLASTIC TALAR IMPACTOR COVER BROKE. "THERE WE NO PARTS OR PIECES CREATED BY THE BREAK THAT COULD HAVE FALLEN INTO THE PATIENT. ALL OF THE PIECES WERE RECOVERED AND DISPOSED OF." PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT RETURN; DISPOSED OF BY HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10859738 ↗

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 Line
• 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