Z-0123-2015Class II

The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total...

Name: Z-0123-2015 The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total...
Creator: Zimmer, Inc.
Published: 2014-10-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-10-07 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona... on 2014-10-07. FDA classified it as Class II and gives the reason as "Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0123-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-07
Posted: 2014-10-23
Terminated: 2015-09-23
Recalling firm: Zimmer GmbH
Product: The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer sent an " URGENT MEDICAL DEVICE RECALL - LOT SPECIFIC " notifications dated September 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Quantity in commerce: 618 units
Distribution: Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
Product codes and lots: Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0123-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0123-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-23

Product code JWH

K113369Class IIZimmer Persona Knee SystemZimmer, Inc. / cleared 2012-03-27

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)