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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 Recall
Cochlear Baha Soft tissue gauge
see related information
Date Posted June 02, 2014
Recall Status1 Open
Recall Number Z-1699-2014
Recall Event ID 68080
Premarket Notification
510(K) Number
K131240 
Product Classification Hearing Aid, Bone Conduction - Product Code LXB
Product Cochlear 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 , Colorado 80111-6511
For Additional Information Contact Tom 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
PRODUCTION CONTROLS: Process Control
Action Customers 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 Commerce 288
Distribution Nationwide Distribution.
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 = LXB and Original Applicant = COCHLEAR AMERICAS
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