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

Recall Z-1016-2013 — Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed

U.S. FDA — Device Enforcement · United States · 2013-01-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1016-2013
Date of alert: 2013-01-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes USA HQ, Inc.
Product category: device
Product type: Devices

Reported risk: The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

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