Device 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.
Z-1699-2014
Product summary
- Event
- Event 68080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 288
- Official record key
device-enforcement:Z-1699-2014
Official wording
Reason: 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.
Code information: Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.