Class 2 Device Recall Persona

• Date Initiated by Firm: August 07, 2014
• Date Posted: September 04, 2014
• Recall Status: Terminated on January 27, 2015
• Recall Number: Z-2578-2014
• Recall Event ID: 68878
• 510(K)Number: K113369 K123459
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• 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.
• 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.
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-613-6131
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On 8/7/2014, Zimmer notified all distributors via electronic mail. Distributors that have received affected inventory are also notified via courier. Hospital risk managers and surgeons are also notified via courier. Hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons.
• Quantity in Commerce: 77,737 total units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH