# FDA recall Z-1634-2020

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-02-27.

## Product

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 pins.

## Reason for recall

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

## Distribution

Nationwide distribution to AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, LA, MA, MI, MN, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV.      International distribution to Turkey, United Kingdom, Thailand, Switzerland, France, Australia.

## Key facts

- **Recall number:** Z-1634-2020
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-27
- **Report date:** 2020-04-08
- **Termination date:** 2024-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1634-2020

## Citation

> AI Analytics. FDA recall Z-1634-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1634-2020. Source: US FDA. Licensed CC0.

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