Medical device recalls Moderate risk

Wright Medical Technology Inc recalls EVOLVE STEM 8.5MM Model # 496S085

Recall date
August 26, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2989-2020
FDA classification
Class II
Brand / firm
Wright Medical Technology Inc
Sold / distributed
USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain

Why it was recalled

Lack of sterility assurance

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

What was recalled

EVOLVE STEM 8.5MM Model # 496S085

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