Z-0690-2017 Class II Terminated
FDA device recall Z-0690-2017 was initiated by Domain Surgical, Inc. on October 24, 2016 and is designated Class II. Reason for recall: Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage. The recall status is terminated (terminated April 11, 2017). Affected quantity: 70 units US; 175 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2016
- Initiation Date
- October 24, 2016
- Termination Date
- April 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units US; 175 units OUS
Product Description
FMsealer Open Shears. Model FM3001
Reason for Recall
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
Distribution Pattern
Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Code Information
Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091