Biomet, Inc. recalls PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
- Recall date
- April 11, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1814-2016
- FDA classification
- Class II
- Brand / firm
- Biomet, Inc.
- Sold / distributed
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Why it was recalled
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
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