Home / Recalls / Domain Surgical, Inc. / Z-0690-2017

Z-0690-2017 Class II Terminated

Recalled by Domain Surgical, Inc. — Salt Lake City, UT

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