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Devices
Novation Element
Model / Serial
Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Distribution to states of: AZ, CO, FL, and MD.
Product Description
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Manufacturer
Exactech, Inc.
1 Event
Recall of Novation Element
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Manufacturer
Exactech, Inc.
Manufacturer Address
Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
Manufacturer Parent Company (2017)
Exactech Inc
Source
USFDA
Language
English
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