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Recall Observatory FDA recall evidence

Device product

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

Z-2155-2015

June 05, 2015

Class II

Product summary

Firm
Cochlear Americas Inc.
Event
Event 71509
Status
Terminated
Classification
Class II
Quantity
26
Official record key
device-enforcement:Z-2155-2015

Official wording

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

Code information: Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15

Distribution pattern: US Nationwide Distribution to CO, OH, OR, MI, and CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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