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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