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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