FDA-Device2016-04-27Class II
VariAx Compression Plating System
Stryker Howmedica Osteonics Corp.
Hazard
Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
Sold states
Nationwide Distribution
Affected count
118 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
VariAx Compression Plating System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1507-2016Don't want to check this manually?
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