Data Foundry

Medical device recalls 2018

Persona Partial Knee System — Class II medical device recall Z-0349-2018

Terminated recall by Zimmer Biomet, Inc., reported 2018-01-24, distributed in AZ, CA, CO, ID, IL, IN, MA, MD…. Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee Sy

Recall numberZ-0349-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Biomet, Inc., Warsaw, IN, United States
Recall initiated2017-07-05
Classified2018-01-14
Reported by FDA2018-01-24
Terminated2019-04-02
DistributedAZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI
Countries outside the USBE, DE, ES, FR, GB, IT, JP, NL, SE
Quantity158 devices
UPC / GTIN / UDI-DI00880304809253, 00880304809338
Lot numbers63518668, 63518669
Model numbers42578100801, 42578100802

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0349-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.