Medical device recalls Moderate risk

Exactech, Inc. recalls Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical…

Recall date
May 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2071-2015
FDA classification
Class II
Brand / firm
Exactech, Inc.
Sold / distributed
Nationwide Distribution to Florida only.

Why it was recalled

Shipped to a single consignee prior to completion of final inspection.

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

What was recalled

Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

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