FDA Recall
Terminated
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
Recall: Z-2155-2015
·
Initiated June 5, 2015
Recall
- Recall Number
- Z-2155-2015
- Event Number
- 71509
- Firm
- Cochlear Americas Inc.
- FEI Number
- 3005900820
- Product Code
- MCM
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 5, 2015
- Posted
- July 20, 2015
- Terminated
- August 5, 2015
- Address
- 13059 E Peakview Ave, Centennial, CO, 80111-6511
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
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Action
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.
Distribution
US Nationwide Distribution to CO, OH, OR, MI, and CA.
Quantity
26