FDA-Device2015-06-17Class II

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

Vilex In Tennessee Inc
Hazard

Incidence of breakage is higher than expected.

Sold states
Distributed in the states of MS, MD, PA, and TX.
Affected count
7 units
Manufactured in
111 Moffitt Street, N/A, Mcminnville, TN, United States
Products
Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1722-2015

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