Z-1699-2014 Class II Terminated
FDA device recall Z-1699-2014 was initiated by Cochlear Americas Inc. on April 9, 2014 and is designated Class II. 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… The recall status is terminated (terminated October 6, 2014). Affected quantity: 288.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2014
- Initiation Date
- April 9, 2014
- Termination Date
- October 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008