Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0014-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2013-03-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0014-2014
Date of alert: 2013-03-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes USA HQ, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0014-2014 — 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.

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