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Synthes USA HQ, Inc. recalls Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of larg
Recalled October 23, 2013 · FDA recall Z-0014-2014 · Synthes USA HQ
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. · FDA Class II
Units
62
Sold at
Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
Description
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.
Product
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.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →