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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Titanium Prosthesis,

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  Class 2 Device Recall Universal Titanium Prosthesis, see related information
Date Initiated by Firm August 23, 2013
Date Posted September 26, 2013
Recall Status1 Terminated 3 on November 07, 2013
Recall Number Z-2284-2013
Recall Event ID 66355
510(K)Number K002897  
Product Classification Total & partial middle ear prostheses, ossicular - Product Code ETA
Product Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Code Information REF: 1150000 Lot: 0207029284
Recalling Firm/
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
FDA Determined
Cause 2
Process control
Action An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.
Quantity in Commerce 60
Distribution Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
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.
510(K) Database 510(K)s with Product Code = ETA and Original Applicant = XOMED, INC.