NA 02.111.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982031389), received between Jan 21, 2021 and Jan 21, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K081071); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HARDWARE REMOVAL FOR SUSPECTED INFECTION WAS PERFORMED. THE IMPLANTS WERE REPLACED ON AN UNKNOWN DATE IN 2017. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 6.5MM MIDFOOT FUSION BOLT 115MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11207620 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081071. One submission often covers many models, so check the product and lot details in each record.

• Z-0014-2014 · Mar 8, 2013 · Terminated
  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.