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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2578-2014
Related Recalls
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.