Z-0596-2018Class II

Persona Partial Knee System

Name: Z-0596-2018 Persona Partial Knee System
Creator: Zimmer Biomet, Inc.
Published: 2017-08-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-08-28 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable... on 2017-08-28. FDA classified it as Class II and gives the reason as "Potential for the Persona Partial Knee Impactor Pad to fracture". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0596-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-28
Posted: 2018-02-14
Terminated: 2018-08-23
Recalling firm: Zimmer GmbH
Product: 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.
Product code: HWA Impactor
Reason for recall: Potential for the Persona Partial Knee Impactor Pad to fracture.
FDA root cause: Under Investigation by firm
Action: Consignees were notified of the recall via letter on about 08/28/2017. Instructions for distributors, sales representatives, and distributor operations leaders include to ensure affected team members are aware of the recall, review the list of hospitals included and note any not included that should be notified, and complete and return the Acknowledgement Form. Instructions for risk managers and surgeons include to ensure affected personnel are aware of the recall, ensure that the provided updated surgical technique is used, and complete and return the Certificate of Acknowledgement. Further questions or concerns can be sent to customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Questions can also be emailed to [email protected].
Quantity in commerce: 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.
Product codes and lots: Item No. 42539909100; Lot No. (UDI No.): 63517759 ((01) 00880304810242 (10) 63517759), 63555750 ((01) 00880304810242 (10) 63555750), 63555752 ((01) 00880304810242 (10) 63555752), 63561883 ((01) 00880304810242 (10) 63561883), 63561884 ((01) 00880304810242 (10) 63561884), 63594911((01) 00880304810242 (10) 63594911), 63594914 ((01) 00880304810242 (10) 63594914), 63698564 ((01) 00880304810242 (10) 63698564), 63705328 ((01) 00880304810242 (10) 63705328)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0596-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0596-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)