Medical device recalls Moderate risk

Encore Medical, Lp recalls Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee ar…

Recall date
September 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0165-2016
FDA classification
Class II
Brand / firm
Encore Medical, Lp
Sold / distributed
US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.

Why it was recalled

The labeling is missing the size/diameter information.

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

What was recalled

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

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