Reported Nov 11, 2015 · Terminated

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems,…

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?

  • Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Lot codes and dates
  • Catalog Number 164-13-09 Serial Numbers
    • 4076815
    • 4076816
    • 4076817
    • 4076818
    • 4076819
    • 4076820
    • 4076821
    • and 4076822
Amount recalled
8

Where it was sold

Why it was recalled

Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

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 Mar 1, 2017 · Data as of Sep 19, 5:21 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.