Recall Z-1723-2015— Vilex In Tennessee Inc

Name: FDA recall Z-1723-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-22

Class II · Terminated

Class II FDA medical device recall by Vilex In Tennessee Inc, initiated 2015-04-22, terminated 2016-10-30. It names one FDA 510(k) clearance: K102413. Product: Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.. Reason: Incidence of breakage is higher than expected..

Recalling firm: Vilex In Tennessee Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Terminated: 2016-10-30
Firm location: Mcminnville, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K102413 — FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILVilex, Inc.·cleared 2011-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

Reason for recall

Incidence of breakage is higher than expected.

Data sourced from openFDA. This site is unofficial and independent of the FDA.