FDA-Device2016-06-08Class II
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Exactech, Inc.
Hazard
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Sold states
Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Affected count
2 devices.
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1901-2016Don't want to check this manually?
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