FDA-Device2015-07-22Class II

Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

Exactech, Inc.
Hazard

Incorrect thread form on the screw.

Sold states
Distributed in the states of FL, GA, IL, NY, TX, and WA.
Affected count
749 devices
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2015

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