Reported Jan 27, 2021 · Ongoing

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

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?

  • Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Lot codes and dates
  • Catalog Number300-01-11
  • Packaging Lot49088921
  • UDI10885862079312
  • Serial Numbers
    • 6477393
    • 6477394
    • 6477395
    • 6477397
    • 6477398
    • 6477399
    • 6477400
    • 6477401
    • 6477402
    • 6477403
    • 6477404
    • 6477405
    • 6477406
    • and 6477407
Amount recalled
14 devices

Where it was sold

Why it was recalled

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

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, 6:19 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.