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Recall Observatory FDA recall evidence

Device 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.

Z-0014-2014

March 08, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 65955
Status
Terminated
Classification
Class II
Quantity
62
Official record key
device-enforcement:Z-0014-2014

Official wording

Reason: 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.

Code information: Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.

Distribution pattern: Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.