Z-0349-2018Class II

Persona Partial Knee System, Size 8, Finishing Guide

Name: Z-0349-2018 Persona Partial Knee System, Size 8, Finishing Guide
Creator: Zimmer Biomet, Inc.
Published: 2017-07-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-07-05 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of Persona Partial Knee System, Size 8, Finishing Guide on 2017-07-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0349-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-05
Posted: 2018-01-14
Terminated: 2019-04-02
Recalling firm: Zimmer GmbH
Product: Persona Partial Knee System, Size 8, Finishing Guide
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were notified via FedEx mail and email on approximately 07/05/2017. Instructions included to notify appropriate personnel, complete and return the Acknowledgement Form, return affected product, and provide contact information of additional hospitals or surgeons that used the affected product.
Quantity in commerce: 158 devices
Distribution: 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.
Product codes and lots: Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0349-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0349-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-14

Product code HSX

K161592Class IIPersona Partial Knee SystemBiomet, Inc. / cleared 2016-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)