Medical device recalls Moderate risk

Exactech, Inc. recalls Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization…

Recall date
March 6, 2009
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2059-2015
FDA classification
Class II
Brand / firm
Exactech, Inc.
Sold / distributed
Distributed in the states of FL, GA, IL, NY, TX, and WA.

Why it was recalled

Incorrect thread form on the screw.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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