Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Recalled by Cochlear Americas Inc. Due to Cochlear Americas is recalling Nucleus Sterile Silicone Template...

Date: June 5, 2015
Company: Cochlear Americas Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cochlear Americas Inc. directly.

Affected 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

Quantity: 26

Why Was This Recalled?

Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cochlear Americas Inc.

Cochlear Americas Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report