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Synthes USA HQ, Inc. recalls Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the
Recalled November 6, 2013 · FDA recall Z-0114-2014 · Synthes USA HQ
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. · FDA Class II
Units
319
Sold at
Worldwide Distribution - US (nationwide) and country of Mexico.
Description
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.
Product
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
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →