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.
This recall has been terminated (originally issued June 2, 2014).
- Company
- Cochlear Americas Inc.
- Recall Initiated
- April 9, 2014
- Posted
- June 2, 2014
- Terminated
- October 6, 2014
- Recall Number
- Z-1699-2014
- Quantity
- 288
- Firm Location
- Centennial, CO
- Official Source
- View on FDA website ↗
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
Nationwide Distribution.
Lot / Code Info
Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
Root Cause
Process control
Action Taken
Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.