FDA-Device2013-11-06Class II
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Synthes USA HQ, Inc.
Hazard
When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
Sold states
Worldwide Distribution - US (nationwide) and country of Mexico.
Affected count
319
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2014Don't want to check this manually?
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