Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less th
FDA device recall Z-1699-2014 · posted 2014-06-02 · Terminated
Recall details
- Recalling firm
- Cochlear Americas Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXB
- Quantity affected
- 288
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-04-09
- Date posted
- 2014-06-02
- Date terminated
- 2014-10-06
- Location
- Centennial, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT (K131240) | Cochlear Americas | 2013-11-07 |