PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 21, 2018 Initiated: August 28, 2017 #Z-0596-2018

Product Description

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.

Reason for Recall

Potential for the Persona Partial Knee Impactor Pad to fracture.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
1,275 units total
Distribution
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.
Location
Warsaw, IN

Frequently Asked Questions

What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 1,275 units total.
Why was this product recalled?
Potential for the Persona Partial Knee Impactor Pad to fracture.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0596-2018.