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Biomet, Inc. recalls PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Recalled June 1, 2016 · FDA recall Z-1814-2016 · Biomet
Hazard
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes. · FDA Class II
Units
22
Sold at
Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Description
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Product
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →