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.
FDA Recall Z-1699-2014 · Posted 2014-06-02
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Recalling FirmCochlear Americas Inc.
Recall StatusTerminated
Product CodeLXB
Date Initiated2014-04-09
Date Terminated2014-10-06
Product Quantity288
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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