Reported Feb 21, 2018 · Terminated

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

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 GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Lot codes and dates
    • Catalog No. 531-15-08
    • Lot No. 75296003
    • 80129003
    • 81327001
Amount recalled
41 devices

Where it was sold

Why it was recalled

Vix Bit may fracture during use.

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

Notice updated Apr 22, 2021 · Data as of Sep 19, 5:32 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.