Reported Apr 27, 2016 · Terminated

VariAx Compression Plating System

Stryker Howmedica Osteonics Corp.

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: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006

Is this the product you have?

  • VariAx Compression Plating System
Lot codes and dates
    • catalog numbers 629503S
    • 629504S
    • 629505S
    • 629506S
    • 629507S
    • 629508S
    • 629509S
    • 629510S
    • 629527S
    • 629537S
    • 629543S
    • 629544S
    • 629545S
    • 629546S
    • 629547S
    • 629548S
    • 629559S
    • 629560S
    • 629561S
    • 629562S
    • 629564S
    • 629566S
    • 629568S
    • 629570S
Amount recalled
118 units

Where it was sold

  • Nationwide

Why it was recalled

Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.

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 21, 2016 · Data as of Sep 19, 6:00 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.