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Cochlear Americas Inc. recalls Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less
Recalled June 11, 2014 · FDA recall Z-1699-2014 · Cochlear Americas
Hazard
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 Class II
Units
288
Sold at
Nationwide Distribution.
Description
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.
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.
Manufacturer(s)
Cochlear Americas Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →