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

Recall Z-1634-2020 — NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone p

U.S. FDA — Device Enforcement · United States · 2020-02-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1634-2020
Date of alert: 2020-02-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices

Reported risk: Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

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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