Medical device recalls Moderate risk

Vilex In Tennessee Inc recalls Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

Recall date
April 22, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1722-2015
FDA classification
Class II
Brand / firm
Vilex In Tennessee Inc
Sold / distributed
Distributed in the states of MS, MD, PA, and TX.

Why it was recalled

Incidence of breakage is higher than expected.

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

What was recalled

Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

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