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
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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 CO 80111-6511
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = LXB
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