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U.S. Department of Health and Human Services

Class 2 Device Recall Lyric Hearing Aid

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  Class 2 Device Recall Lyric Hearing Aid see related information
Date Initiated by Firm January 19, 2010
Date Posting Updated May 26, 2010
Recall Status1 Terminated 3 on August 02, 2011
Recall Number Z-1681-2010
Recall Event ID 54473
510(K)Number K081136  
Product Classification hearing aid - Product Code ESD
Product InSound Medical, Inc, Lyric in-canal hearing aid.
Code Information All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.
Recalling Firm/
Manufacturer
InSound Medical, Inc.
37500 Central Ct
Newark CA 94560-3454
For Additional Information Contact
510-792-4000 Ext. 470
Manufacturer Reason
for Recall
Manufacturing error could result in electrolyte leakage from the product's battery.
FDA Determined
Cause 2
Process design
Action InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.
Quantity in Commerce 2019 units
Distribution Distribution only in US ( nationwide). No foreign consignees involved.
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 = ESD and Original Applicant = INSOUND MEDICAL INC.
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