Devices

Device Recall Cochlear Nucleus Sterile Silicone Template

Model / Serial
Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
Product Classification
Ear, Nose, and Throat Devices
Device Class
3
Implanted device?
Yes
Distribution
US Nationwide Distribution to CO, OH, OR, MI, and CA.
Product Description
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
Manufacturer
Cochlear Americas Inc.
1 Event
- Recall of Device Recall Cochlear Nucleus Sterile Silicone Template

Manufacturer

Cochlear Americas Inc.

Manufacturer Address
Cochlear Americas Inc., 13059 E Peakview Ave, Centennial CO 80111-6511
Manufacturer Parent Company (2017)
Cochlear Ltd.
Source
USFDA

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