FDA-Device2015-07-29Class II
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
Cochlear Americas Inc.
Hazard
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Sold states
US Nationwide Distribution to CO, OH, OR, MI, and CA.
Affected count
26
Manufactured in
13059 E Peakview Ave, N/A, Centennial, CO, United States
Products
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2155-2015Don't want to check this manually?
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