FDA-Device2016-06-01Class II
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Biomet, Inc.
Hazard
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Sold states
Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Affected count
22
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1814-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief