Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0024-2022 — 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 Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated

U.S. FDA — Device Enforcement · United States · 2021-08-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0024-2022
Date of alert
2021-08-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10885862276216
Reported risk: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.