Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals recalled over labeling errors
- Recall date
- October 9, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Exactech, Inc. recalls Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usa…
- Recall number
- Z-0906-2015
- FDA classification
- Class II
- Brand / firm
- Exactech, Inc.
- Sold / distributed
- International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
Why it was recalled
Mislabeled
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
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