Medical device recalls Moderate risk

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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