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Recall Observatory FDA recall evidence

Device product

PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.

Z-2578-2014

August 07, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68878
Status
Terminated
Classification
Class II
Quantity
77,737 total units
Official record key
device-enforcement:Z-2578-2014

Official wording

Reason: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.

Code information: Part Numbers: 42517000303, 42517000313, 42517000505, 42517000515, 42517000707, 42517000717, 42517000909, 42517000919, 42527000303, 42527000313, 42527000505, 42527000515, 42527000707, 42527000717, 42527000909, and 42527000919. Lot numbers:62022340, 62024973, 62062232, 62104367, 62187314, 62187315, 62190367, 62190370, 62265725, 62301862, 62314675, 62355857, 62385126, 62385132, 62403987, 62414017, 62420244, 62456269, 62506026, 62506044, 62531664, 62558106, 62564325, 62596552, 62600208, 62614790, 62683419, 62691385, 62698730, 62716777, 62751902, 62752809, 62765288, 62774042, 62024974, 62032099, 62075271, 62144791, 62171682, 62171684, 62184223, 62187317, 62239237, 62248153, 62256256, 62386757, 62391108, 62391109, 62414001, 62414002, 62456271, 62474902, 62544384, 62565106, 62565107, 62601564, 62612269, 62627270, 62678888, 62684675, 62695301, 62710627, 62745014, 62745021, 62019862, 62091183, 62177238, 62177239, 62177240, 62268818, 62282708, 62305406, 62314683, 62351287, 62356123, 62385455, 62401419, 62405946, 62419059, 62429198, 62456279, 62504887, 62531665, 62559945, 62565049, 62595861, 62621822, 62627202, 62663169, 62690886, 62696853, 62698724, 62710616, 62716769, 62752807, 62778335, 62030854, 62050136, 62125572, 62154284, 62165540, 62168382, 62177242, 62190375, 62247344, 62247345, 62256257, 62364951, 62391110, 62391111, 62413998, 62413999, 62427064, 62469454, 62525495, 62538399, 62565109, 62565110, 62565111, 62595858, 62630285, 62632817, 62680122, 62680123, 62691389, 62696886, 62710624, 62717356, 62737725, 62741936, 62022342, 62024977, 62087042, 62091198, 62165542, 62187321, 62189343, 62233919, 62239239, 62247347, 62256279, 62386756, 62391114, 62391115, 62403989, 62419057, 62429191, 62461234, 62525494, 62544359, 62564327, 62587605, 62601573, 62601574, 62668825, 62696851, 62717321, 62744886, 62747704, 62756025, 62029578, 62030862, 62125573, 62165544, 62189322, 62189323, 62189324, 62201539, 62239240, 62247349, 62256280, 62372408, 62386777, 62391226, 62403995, 62420263, 62456272, 62506051, 62544380, 62565113, 62565114, 62595867, 62663132, 62668575, 62689234, 62691387, 62717344, 62338672, 62338673, 62338674, 62338675, 62504658, 62511928, 62564328, 62619534, 62383954, 62427416, 62443506, 62495522, 62498723, 62669167, 62710621, 62055685, 62075277, 62149177, 62192902, 62192903, 62198204, 62233922, 62305408, 62356554, 62385133, 62385134, 62404280, 62420241, 62449201, 62515528, 62529691, 62551363, 62564308, 62604993, 62614838, 62616391, 62683416, 62715142, 62715143, 62724729, 62732162, 62751548, 62043562, 62104420, 62166222, 62196582, 62196583, 62196584, 62233923, 62305409, 62356575, 62356576, 62386778, 62404281, 62419055, 62427063, 62449190, 62497269, 62544355, 62565097, 62565098, 62595870, 62600182, 62608888, 62677155, 62678897, 62696859, 62710617, 62730175, 62736055, 62751908, 62043563, 62091814, 62177255, 62188407, 62188408, 62188409, 62233924, 62305410, 62356580, 62356582, 62386427, 62429080, 62429081, 62442784, 62479530, 62480204, 62480205, 62544357, 62544358, 62568264, 62569954, 62592280, 62595862, 62611084, 62641326, 62654924, 62695307, 62710625, 62740696, 62751896, 62763428, 62036671, 62125597, 62144797, 62203401, 62203402, 62209047, 62229714, 62239297, 62248169, 62315063, 62356591, 62364962, 62386780, 62391235, 62419058, 62442845, 62469460, 62531658, 62551097, 62568294, 62654893, 62654894, 62663171, 62683434, 62702755, 62055687, 62089764, 62189328, 62209048, 62229720, 62239303, 62290779, 62311023, 62315137, 62351301, 62356596, 62386781, 62391238, 62404283, 62420245, 62449209, 62504870, 62544366, 62565096, 62581866, 62597790, 62608891, 62612281, 62683418, 62686270, 62724731, 62724732, 62758011, 62046410, 62125598, 62149716, 62187330, 62187331, 62239305, 62239306, 62248170, 62320808, 62356601, 62385135, 62385136, 62404284, 62420257, 62449213, 62504874, 62529692, 62558587, 62581868, 62600187, 62608890, 62627268, 62684651, 62689233, 62690894, 62702304, 62702306, 62710622, 62394886, 62400296, 62428415, 62443507, 62500932, 62500933, 62551242, 62597759, 62646280, 62660204, 62380844, 62399812, 62428395, 62443504, 62493131, 62536079, 62564309, 62632816, and 62695868.

Distribution pattern: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.