Orthosensor, Inc. recalls Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during ortho…
- Recall date
- December 5, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1029-2015
- FDA classification
- Class II
- Brand / firm
- Orthosensor, Inc.
- Sold / distributed
- US Distribution to the states of : IL, MI, NY, CA, VA and NV.
Why it was recalled
Presence of one inoperable (dead) sensor pad.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
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