FDA Device

FMsealer Open Shears. Model FM3001

Hazard

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

What You Should Do

Remedy

Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.

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Products

FMsealer Open Shears. Model FM3001
Brand
Domain Surgical, Inc.
UPC
Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091

Units Affected

70 units US; 175 units OUS

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