Zimmer Biomet, Inc. recalls Persona Partial Knee System, Size 8, Finishing Guide

Recall date

July 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0349-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Persona Partial Knee System, Size 8, Finishing Guide