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
This recall has been terminated (originally issued July 20, 2015).
- Company
- Cochlear Americas Inc.
- Recall Initiated
- June 5, 2015
- Posted
- July 20, 2015
- Terminated
- August 5, 2015
- Recall Number
- Z-2155-2015
- Quantity
- 26
- Firm Location
- Centennial, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Distribution
US Nationwide Distribution to CO, OH, OR, MI, and CA.
Lot / Code Info
Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
Root Cause
Process control
Action Taken
Cochlear sent an Urgent Medical Device Recall letter dated June 5, 2015 via Fed-Ex shipment. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected products for replacement.