Reported Jan 14, 2015 · Terminated

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03.…

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?

  • Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03
  • UsageFemoral implants
Lot codes and dates
    • Catalog #244-02-03
    • Serial # 2925147 - 2925194
    • Catalog #244-03-0
    • Serial #2925246 - 2925293
Amount recalled
96

Why it was recalled

Mislabeled

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 Jun 8, 2016 · Data as of Sep 19, 4:53 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.