FDA-Device2018-12-26Class II
NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
Zimmer Biomet, Inc.
Hazard
Screw is missing from the package
Sold states
Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.
Affected count
19 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0630-2019Don't want to check this manually?
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