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

Recall Z-3143-2017 — Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the su

U.S. FDA — Device Enforcement · United States · 2017-06-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3143-2017
Date of alert: 2017-06-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Navigation, Inc.
Product category: device
Product type: Devices

Reported risk: Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.

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.

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