FDA-Device2017-01-25Class II

Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

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
98
Manufactured in
2320 NW 66th Ct, Gainesville, FL, United States
Products
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1032-2017

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