Recall Z-2155-2015 ยท MCM Implant, Cochlear
Cochlear Americas Inc.
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
| Date | Jul 20, 2015 (initiated Jun 5, 2015) |
| Status | Terminated |
| Reason | Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed. |
| Root cause | Process control |
| 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. |
| Quantity | 26 |
| Distribution | US Nationwide Distribution to CO, OH, OR, MI, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.