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
FDA Recall Z-2155-2015 · Posted 2015-07-20
Recalling FirmCochlear Americas Inc.
Recall StatusTerminated
Product CodeMCM
Date Initiated2015-06-05
Date Terminated2015-08-05
Product Quantity26
Reason for Recall
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Firm Action
Cochlear sent an Urgent Medical Device Recall letter dated June 5, 2015 via Fed-Ex shipment. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected products for replacement.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution to CO, OH, OR, MI, and CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.