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U.S. Department of Health and Human Services

Class 2 Device Recall Cochlear Nucleus Sterile Silicone Template

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  Class 2 Device Recall Cochlear Nucleus Sterile Silicone Template see related information
Date Initiated by Firm June 05, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Cochlear Americas
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