FDAFDA · Food and drugs·Recall number Z-2578-2014
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.
Published September 10, 2014 · Recall initiated: August 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- 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.
- Lot
- 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, 6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.