Medical device recalls Moderate risk

Orthosensor, Inc. recalls OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

Recall date
July 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0085-2019
FDA classification
Class II
Brand / firm
Orthosensor, Inc.
Sold / distributed
Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

Why it was recalled

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

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

What was recalled

OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

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