Medical device recalls Moderate risk

Wright Medical Technology Inc recalls INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

Recall date
November 4, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0315-2022
FDA classification
Class II
Brand / firm
Wright Medical Technology Inc
Sold / distributed
US Nationwide distribution in the states of MI and PA.

Why it was recalled

The package contents and package labeling do not match.

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

What was recalled

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

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