Class 2 Device Recall Cochlear Nucleus Sterile Silicone Template

• Date Initiated by Firm: June 05, 2015
• Date Posted: July 20, 2015
• Recall Status: Terminated on August 05, 2015
• Recall Number: Z-2155-2015
• Recall Event ID: 71509
• PMA Number: P970051
• Product Classification: Implant, cochlear - Product Code MCM
• Product: 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
• Code Information: Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
• Recalling Firm/ Manufacturer: Cochlear Americas Inc.; 13059 E Peakview Ave; Centennial CO 80111-6511
• For Additional Information Contact: Tom Pavlik; 303-264-2367
• Manufacturer Reason for Recall: Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
• FDA Determined 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 in Commerce: 26
• Distribution: US Nationwide Distribution to CO, OH, OR, MI, and CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MCM