Vantage 351-10-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862290878), received between Apr 15, 2019 and Jul 5, 2023 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2023Break; Break

  AS REPORTED, DURING SHIPPING/RECEIVING, WHEN THE LOANER KIT RETURNED TO OUR WAREHOUSE, OUR TEAM RECOGNIZED THE BREAKAGE OF THE DEVICE. DURING SURGICAL USE, HARD SCLEROTIC BONE WAS DETECTED IN THE YOUNG PATIENT WHICH LED TO THE NECESSITY OF APPLYING MORE FORCE TO THE IMPACTOR. IN CONCLUSION, THE FORCE LED TO A BREAKAGE OF THE DEVICE. THERE WAS NO NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE AND THERE WAS LESS THAN 5-MINUTES SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE PRODUCT WILL BE RETURN. NO OTHER SURGICAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260412 ↗
• MalfunctionFeb 7, 2023Break; Break

  DURING SURGERY, THE SURGEON ASKED FOR THE CENTER IMPACTION INSTRUMENT FOR THE TIBIAL IMPLANT ON THE VANTAGE SYSTEM. THEY IMPACTED THE TIBIA, BUT THE BONE WAS SCLEROTIC, DUE TO A PREVIOUS FRACTURE, SO THE SURGEON IMPACTED A SECOND TIME AND WHEN THEY RETURNED THE INSTRUMENT TO THE SCRUB PRACTITIONER IT WAS NOTICED THAT THE TIP OF THE INSTRUMENT HAD FRACTURED OFF. THE TIP WAS REMOVED FROM THE TIBIA OF THE PATIENT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310773 ↗
• MalfunctionJun 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 14859398 ↗
• InjuryAug 19, 2020Break; Break

  AS REPORTED, DURING THE PUNCH GUIDE BROKE DURING THE IMPACTION. NO PARTS OR PIECES FELL INTO THE WOUND SITE. THERE WAS NO IMPACT TO THE PATIENT. DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425637 ↗
• InjuryApr 15, 2019Improper or Incorrect Procedure or Method

  SURGEON DID NOT CUT CORRECTLY SO THE FOOT WAS AFTER SURGERY STILL IN VARUS AND THE TIBIAL PLATE DID NOT INTEGRATE. HE NEEDED TO EXCHANGE THE TIBIAL COMPONENT AND THE TALAR INSERT.

  Patient problems: No Code Available

  MAUDE report 8514004 ↗

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-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