Reported Dec 27, 2023 · Ongoing

Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03

Exactech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630

Is this the product you have?

  • Exactech Vantage Mobile Bearing Tibial Inserts
  • Catalog Numbers
    • a) 350-41-23
    • b) 350-42-03
Lot codes and dates
  • a) 350-41-23, GTIN none
  • Serial Numbers
    • A658148
    • b) 350-42-03
    • GTIN none
  • Serial Numbers
    • A688867
    • A688880
    • A688864
    • A688868
    • A688870
    • A688872
    • A688873
    • A688876
    • A688879
    • A688881
    • A688882
Amount recalled
N/A

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

Why it was recalled

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.