Medical device recalls Moderate risk

Domain Surgical, Inc. recalls FMsealer Open Shears. Model FM3001

Recall date
October 24, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0690-2017
FDA classification
Class II
Brand / firm
Domain Surgical, Inc.
Sold / distributed
Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FMsealer Open Shears. Model FM3001

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