Zimmer Biomet, Inc. recalls Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilit…

Recall date

August 28, 2017

Source

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

Recall number

Z-0596-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

US Nationwide Distribution in the states of 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, Switzerland, UK.

Why it was recalled

Potential for the Persona Partial Knee Impactor Pad to fracture.

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 Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.