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

Recall Z-3141-2017 — Spine Referencing Instrumentation, Double Spinous Process Clamp, 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 surgery. The devices

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-3141-2017
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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