Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0349-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Persona Partial Knee System, Size 8, Finishing Guide

Product Classification:

Class II

Date Initiated: July 5, 2017

Date Posted: January 24, 2018

Recall Number: Z-0349-2018

Event ID: 78725

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.

Status: Terminated

Product Quantity: 158 devices

Code Information:

Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated