# FDA recall Z-0349-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-07-05.

## Product

Persona Partial Knee System, Size 8, Finishing Guide

## Reason for recall

Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.

## Distribution

Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI.      Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.

## Key facts

- **Recall number:** Z-0349-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-05
- **Report date:** 2018-01-24
- **Termination date:** 2019-04-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0349-2018

## Citation

> AI Analytics. FDA recall Z-0349-2018. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0349-2018. Source: US FDA. Licensed CC0.

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