Domain Surgical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0690-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

FMsealer Open Shears. Model FM3001

Product Classification:

Class II

Date Initiated: October 24, 2016

Date Posted: December 7, 2016

Recall Number: Z-0690-2017

Event ID: 75627

Reason for Recall:

Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.

Status: Terminated

Product Quantity: 70 units US; 175 units OUS

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.

Voluntary or Mandated:

Voluntary: Firm initiated