Medical device recalls Moderate risk

Exactech, Inc. recalls Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intend…

Recall date
September 23, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0201-2016
FDA classification
Class II
Brand / firm
Exactech, Inc.
Sold / distributed
US Distribution to states of: AZ, CO, FL, and MD.

Why it was recalled

Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

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

What was recalled

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

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