FDA-Device2017-01-25Class II
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Exactech, Inc.
Hazard
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Sold states
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Affected count
79 units
Manufactured in
2320 NW 66th Ct, Gainesville, FL, United States
Products
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2017Don't want to check this manually?
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