FDA-Device2013-12-04Class II
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Synthes USA HQ, Inc.
Hazard
A plate was inadvertently released to a sales consultant that was restricted for sale.
Sold states
US Distribution in Colorado.
Affected count
1
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2014Don't want to check this manually?
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