FDA-Device2014-02-26Class II
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Synthes, Inc.
Hazard
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
Affected count
1,132,096
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0986-2014Don't want to check this manually?
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