Z-2299-2014Class II

Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L...

Name: Z-2299-2014 Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L...
Creator: Zimmer, Inc.
Published: 2013-06-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-06-10 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH... on 2013-06-10. FDA classified it as Class II and gives the reason as "Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year...". 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-2299-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2014-08-21
Terminated: 2014-09-11
Recalling firm: Zimmer GmbH
Product: Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
Root cause tag: design
FDA root cause: Device Design
Action: On February 10, 2014, Zimmer sent letter to surgeons who had filed complaints regarding the affected TASP fractures. The letter provided the surgeons with Zimmer's investigational findings of the issue. Surgeons were directed to send questions or any additional informtion to [email protected]. The Zimmer Weekly Wrap-Up, dated February 14, 2014, was issued electronically to sales force. They were notified to engage in mandatory training to improve the usage of the TASPs and prevent potential breakage. Zimmer has taken additional corrective measures by initiating another recall in July 2014 whereby they notify the distributors as well as all users of the enhanced surgical technique.
Quantity in commerce: 70,986 distribution events
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
Product codes and lots: Item Numbers: 42517200410 42517200510 42517200610 42517200710 Lot Numbers: 62034570 62117742 62156315 62187322 62247350 62314721 62372409 62381836 62397160 62429190 62474906 62551390 62565048 62595853 62614781 62700416 62702297 62724349 62043548 62055681 62104368 62117743 62144794 62165545 62177246 62256282 62351288 62356244 62391228 62427419 62456268 62506003 62551338 62564355 62597762 62614786 62702292 62705808 62717332 62055682 62068376 62068378 62144795 62152727 62187323 62256283 62351289 62386419 62356275 62445931 62456266 62558584 62575757 62611087 62638672 62698749 62330130 62563854 62567418

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2299-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2296-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21
Z-2297-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21
Z-2298-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21
Z-2299-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21
Z-2300-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21
Z-2301-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21

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)