Z-2578-2014 Class II Terminated
FDA device recall Z-2578-2014 was initiated by Zimmer, Inc. on Aug 7, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 27, 2015). Affected quantity: 77,737 total units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 10, 2014
- Initiation Date
- Aug 7, 2014
- Termination Date
- Jan 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77,737 total units
Product Description
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.
Reason for Recall
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2578-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026