Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended t...
FDA Recall #Z-2059-2015 — Class II — March 6, 2009
Product Description
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Reason for Recall
Incorrect thread form on the screw.
Recalling Firm
Exactech, Inc. — Gainesville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
749 devices
Distribution
Distributed in the states of FL, GA, IL, NY, TX, and WA.
Code Information
Catalog Number 28202, Lot Number AS05107
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated