Z-0198-2015Class II

Persona Stemmed 5 Degree Cemented Tibia

Name: Z-0198-2015 Persona Stemmed 5 Degree Cemented Tibia
Creator: Zimmer, Inc.
Published: 2014-10-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-10-09 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis... on 2014-10-09. FDA classified it as Class II and gives the reason as "Cleaning process validation failure". 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-0198-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Posted: 2014-11-08
Terminated: 2015-06-24
Recalling firm: Zimmer GmbH
Product: Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Cleaning process validation failure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer sent an Urgent Medical Device Recall letter dated October 9, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer sales representative with the quarantine of any affected product. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759. Hours of operation are Monday through Friday, 8 a.m. through 8 p.m. EST.
Quantity in commerce: 138 units
Distribution: US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
Product codes and lots: Part Number 42-5320-079-02 Lot Number 62613813 Part Number 42-5320-071-02 Lot Number 62625781 Part Number 42-5320-075-01 Lot Number 62619031 Part Number 42-5320-075-01 Lot Number 62619040 Part Number 42-5320-079-01 Lot Number 62626696 Part Number 42-5320-071-01 Lot Number 62625790

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0198-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0198-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-08

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)