Medical device recalls Moderate risk

Integra LifeSciences Corp. recalls Integra Cadence Total Ankle System

Recall date
January 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1192-2017
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp.
Sold / distributed
Nationwide

Why it was recalled

Posterior tibial fractures have been reported.

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

What was recalled

Integra Cadence Total Ankle System

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