Recall Z-0690-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Domain Surgical, Inc.
FMsealer Open Shears. Model FM3001
| Date | Dec 1, 2016 (initiated Oct 24, 2016) |
| Status | Terminated |
| Reason | Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage. |
| Root cause | Other |
| Action | Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc. |
| Quantity | 70 units US; 175 units OUS |
| Distribution | Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141484 | OPEN FMSEALER Domain Surgical, Inc., Jul 30, 2014 |