Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0014-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 8, 2013

Date Posted: October 23, 2013

Recall Number: Z-0014-2014

Event ID: 65955

Reason for Recall:

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.

Status: Terminated

Product Quantity: 62

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.

Voluntary or Mandated:

Voluntary: Firm initiated