Recall Z-1699-2014 ยท LXB Hearing Aid, Bone Conduction
Cochlear Americas Inc.
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.
| Date | Jun 2, 2014 (initiated Apr 9, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products. |
| Quantity | 288 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT Cochlear Americas, Nov 7, 2013 |