Reported Jul 29, 2015 · Terminated

Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in…

Cochlear Americas Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cochlear Americas Inc. · 13059 E Peakview Ave · Centennial, CO · 80111-6511

Is this the product you have?

  • Cochlear Nucleus
  • Sterile Silicone Template Product UsageThe 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
Lot codes and dates
  • Lot numbersCOH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
Amount recalled
26

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 5, 2015 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.