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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 gauge see related information
Date Initiated by Firm April 09, 2014
Date Posted June 02, 2014
Recall Status1 Terminated 3 on October 06, 2014
Recall Number Z-1699-2014
Recall Event ID 68080
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/
Cochlear Americas Inc.
13059 E Peakview Ave
Centennial CO 80111-6511
For Additional Information Contact Tom Pavlik
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
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 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 = LXB and Original Applicant = COCHLEAR AMERICAS