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

Recall Insight

This FDA Devices action (record #Z-2155-2015) was formally reported on July 29, 2015, with the manufacturer initiating the action on June 5, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Cochlear Americas Inc. is listed as the recalling firm, operating out of Centennial, CO. Federal records indicate 26 units are affected.

The documented reason for this recall is: Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed. Distribution data in the federal record shows the product reached: US Nationwide Distribution to CO, OH, OR, MI, and CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.