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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