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U.S. Department of Health and Human Services

Class 2 Device Recall Cochlear Baha Soft tissue gauge

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 Class 2 Device Recall Cochlear Baha Soft tissue gaugesee related information
Date Initiated by FirmApril 09, 2014
Date PostedJune 02, 2014
Recall Status1 Terminated 3 on October 06, 2014
Recall NumberZ-1699-2014
Recall Event ID 68080
510(K)NumberK131240 
Product Classification Hearing aid, bone conduction - Product Code LXB
ProductCochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Code Information Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
Recalling Firm/
Manufacturer
Cochlear Americas Inc.
13059 E Peakview Ave
Centennial CO 80111-6511
For Additional Information ContactTom Pavlik
303-264-2367
Manufacturer Reason
for Recall
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
FDA Determined
Cause 2
Process control
ActionCustomers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.
Quantity in Commerce288
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LXB
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