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Recall Observatory FDA recall evidence

Device product

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

Z-2298-2014

June 10, 2013

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68817
Status
Terminated
Classification
Class II
Quantity
70,986 distribution events
Official record key
device-enforcement:Z-2298-2014

Official wording

Reason: 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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.