Vantage 350-22-43Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862293275), received between Apr 13, 2023 and Dec 26, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL RIGHT TAA, THE 63 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A RECALLED POLY. PATIENT WAS REVISED WITH EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE DEVICE.

  Patient problems: Pain

  MAUDE report 18395266 ↗
• InjuryApr 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  LEGAL CASE: (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT, A 62 YEAR OLD MALE, IS VERIFIED RIGHT ANKLE ON (B)(6) 2018 AND A RIGHT ANKLE REVISION ON (B)(6) 2022, APPROXIMATELY 3 YEARS AND 11 MONTHS AFTER THEIR INITIAL SURGERY. POSTOPERATIVE DIAGNOSIS: PAINFUL RIGHT TOTAL ANKLE REPLACEMENT, PERIPROSTHETIC CYST UNDERNEATH THE TALUS. INSPECTION OF THE POLYETHYLENE DEMONSTRATED NO EVIDENCE OF FRACTURE OR DELAMINATION. THE TIBIA AND TALAR COMPONENTS WERE INSPECTED AND WERE STABLE. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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. SERIAL#: (B)(4), CATEGORY#: 350-22-43 - TIBIAL INSERT FB SZ 3 RT 10MM, SERIAL NUMBER: (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K152217. CONCOMITANTS: SERIAL#: (B)(4), CATEGORY#: 350-02-03 - TALAR IMPLANT SZ 3 RT, SERIAL#: (B)(4), CATEGORY#: 350-10-04 - ANKLE SZ 4 LOCKING CLIP, SERIAL#:(B)(4), CATEGORY#: 350-12-04 - TIBIAL PLATE FB SZ 4 RT.

  Patient problems: Cyst(s)

  MAUDE report 16736571 ↗

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