Recall Z-1699-2014— Cochlear Americas Inc.
Class II · Terminated
Class II FDA medical device recall by Cochlear Americas Inc., initiated 2014-04-09, terminated 2014-10-06. It names one FDA 510(k) clearance: K131240. 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.. 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..
- Recalling firm
- Cochlear Americas Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-09
- Terminated
- 2014-10-06
- Firm location
- Centennial, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.