FMsealer Open Shears. Model FM3001
FDA device recall Z-0690-2017 · posted 2016-12-01 · Terminated
Recall details
- Recalling firm
- Domain Surgical, Inc.
- Reason for recall
- Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
- Action taken
- Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 70 units US; 175 units OUS
- Distribution
- Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
- Date initiated
- 2016-10-24
- Date posted
- 2016-12-01
- Date terminated
- 2017-04-11
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPEN FMSEALER (K141484) | Domain Surgical, Inc. | 2014-07-30 |