FDA-Device2013-10-23Class II
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Synthes USA HQ, Inc.
Hazard
A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
Sold states
Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
Affected count
62
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0014-2014Don't want to check this manually?
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