FDA-Device2015-11-11Class II
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Exactech, Inc.
Hazard
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Sold states
US Distribution to states of: AZ, CO, FL, and MD.
Affected count
8
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2016Don't want to check this manually?
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