InSound Medical, Inc, Lyric in-canal hearing aid.
FDA device recall Z-1681-2010 · posted 2010-05-26 · Terminated
Recall details
- Recalling firm
- InSound Medical, Inc.
- Reason for recall
- Manufacturing error could result in electrolyte leakage from the product's battery.
- Action taken
- InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.
- Root cause
- Process design
- Status
- Terminated
- Product code
- ESD
- Quantity affected
- 2019 units
- Distribution
- Distribution only in US ( nationwide). No foreign consignees involved.
- Date initiated
- 2010-01-19
- Date posted
- 2010-05-26
- Date terminated
- 2011-08-02
- Location
- Newark, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LYRIC HEARING AID (K081136) | Insound Medical, Inc. | 2008-05-08 |