Z-2155-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- June 5, 2015
- Termination Date
- August 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
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
Reason for Recall
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Distribution Pattern
US Nationwide Distribution to CO, OH, OR, MI, and CA.
Code Information
Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15