FDA-Device2026-01-21Class II
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Medicrea International
Hazard
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Sold states
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Affected count
44 units
Manufactured in
5389 route de Strasbourg, Vancia, Rillieux La Pape, France
Products
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1038-2026Don't want to check this manually?
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