Z-2301-2014Class II

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

Name: Z-2301-2014 Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC 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 CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF... 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-2301-2014
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 CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH 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: 42517600410 42517600510 42517600610 42517600710 42517600810 42517600910 Lot Numbers: 62342526 62423918 62423919 62423920 62427414 62482212 62563745 62612225 62656072 62740698 62342527 62405895 62430401 62504179 62511925 62563784 62638665 62695870 62343066 62406967 62432146 62515486 62564324 62691390 62717335 62351291 62374838 62415307 62430397 62518138 62622527 62696875 62357867 62374796 62427836 62441229 62511924 62565948 62563908 62590523 62695295 62361315 62376662 62420192 62434748 62518137 62540059 62563778 62627131 62698733

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2301-2014
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

K123459Class IIZimmer Persona Tm Personalized Knee SystemZimmer, Inc. / cleared 2013-02-22

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)