Z-2298-2014 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-2298-2014 was initiated by Zimmer, Inc. on Jun 10, 2013 and is designated Class II. 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… The recall status is terminated (terminated Sep 11, 2014). Affected quantity: 70,986 distribution events.

Recall Details

Product Type
Devices
Report Date
Aug 27, 2014
Initiation Date
Jun 10, 2013
Termination Date
Sep 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70,986 distribution events

Product Description

Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

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.

Distribution Pattern

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.

Code Information

Item Numbers: 42517000410 Lot Numbers: 62024975 62043546 62144792 62152725 62165538 62187318 62337961 62372407 62386776 62397159 62405917 62456263 62499170 62551386 62568272 62572572 62565051 62663168 62691384 62707494 62717346

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2298-2014
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.