FDAFDA · Food and drugs·Recall number Z-1814-2016
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Published June 1, 2016 · Recall initiated: April 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
- Lot
- PerFuse Decompression Instrument PN: 800-0541, Lot:100650
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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