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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 Recall
Universal Titanium Prosthesis,
see related information
Date Posted September 26, 2013
Recall Status1 Terminated on November 07, 2013
Recall Number Z-2284-2013
Recall Event ID 66355
Premarket Notification
510(K) Number
K002897 
Product Classification Replacement, Ossicular Prosthesis, Total - 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/
Manufacturer
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville, Florida 32216-6218
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Customer Service
800-874-5797
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = ETA and Original Applicant = XOMED, INC.
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