FDA-Device2014-07-30Class II
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Exactech, Inc.
Hazard
The femoral stem is lacking specified plasma coating.
Sold states
Worldwide Distribution including Spain, Greece and Japan
Affected count
10
Manufactured in
2320 NW 66th Ct, Gainesville, FL, United States
Products
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2086-2014Don't want to check this manually?
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