Medical device recalls Moderate risk

Cochlear Americas Inc. recalls Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in th…

Recall date
June 5, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2155-2015
FDA classification
Class II
Brand / firm
Cochlear Americas Inc.
Sold / distributed
US Nationwide Distribution to CO, OH, OR, MI, and CA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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