Reported Dec 27, 2023 · Ongoing

Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

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 Ankle System
  • Catalog Numbers
    • a) 350-21-04
    • b) 350-22-03
Lot codes and dates
    • a) 350-21-04
    • GTIN 10885862276247
  • Serial Numbers
    • A644020
    • b) 350-22-03
    • GTIN 10885862276353
  • Serial Numbers
    • A641653
    • A641655
    • A641659
    • A641660
    • A641662
    • A641663
    • A641666
    • A641667
    • A641668
    • A641669
    • A641672
    • A641654
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Exactech, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 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.