Device product
FMsealer Open Shears. Model FM3001
Z-0690-2017
Product summary
- Event
- Event 75627
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 units US; 175 units OUS
- Official record key
device-enforcement:Z-0690-2017
Official wording
Reason: Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
Code information: Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091
Distribution pattern: Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Derived failure modes
-
Unknown
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.