Z-0540-2013Class II

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device...

Name: Z-0540-2013 Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device...
Creator: Zimmer, Inc.
Published: 2012-11-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-11-14 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain... on 2012-11-14. FDA classified it as Class II and gives the reason as "All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with...". 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-0540-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-14
Posted: 2012-12-18
Terminated: 2014-04-16
Recalling firm: Zimmer GmbH
Product: Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to [email protected] within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts. For questions regarding this recall call 574-372-4807.
Quantity in commerce: 518
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
Product codes and lots: Part Number 42-5320-067-01 TIBIA SIZE D, LEFT, Lot: 62018341, 62018342, 62030572, 62030573, 62033385, 62051022, 62068416, 62076576, 62079742, 62091362, 62103717, 62103718, 62110194, 62117656, 11007593, 11007636, 11007592, 11007635, 11007594, 11007634 Part Number 42-5320-067-02 TIBIA SIZE D RIGHT, Lot: 11006514, 11007138, 11007214, 62018343, 62018344, 62033386, 62040513, 62060743, 62068417, 62076577, 62079743, 62079744, 62091363, 62103720, 62117657, 11007589, 11007590, 11007591, 11007637, 11007638, 11007639, 62140222

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0540-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0539-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0540-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0541-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0542-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0543-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0544-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0545-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0546-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0547-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0548-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0549-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0550-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0551-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0552-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0553-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0554-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18
Z-0555-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)