Device product
PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top.
Z-2579-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77,737 total units
- Official record key
device-enforcement:Z-2579-2014
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: 42517400410, 42517400510, 42517400610, 42517400710, 42517400810, 42517400910, 42517401010, 42517401110, 42527400410, 42527400510, 42527400610, 42527400710, 42527400810, 42527400910, 42527401010, and 42527401110. Lot numbers:62043556, 62110045, 62121489, 62125589, 62147235, 62165546, 62168383, 62177247, 62311021, 62314722, 62386421, 62442838, 62525491, 62558585, 62605208, 62627292, 62683432, 62696865, 62717343, 62022344, 62041351, 62073566, 62104372, 62117744, 62121488, 62149175, 62187324, 62187325, 62247351, 62311022, 62314723, 62364961, 62391117, 62436468, 62474903, 62538403, 62564311, 62611089, 62669905, 62690895, 62720225, 62742767, 62747707, 62020946, 62028233, 62073570, 62110047, 62130976, 62187327, 62187329, 62189325, 62290822, 62305407, 62314724, 62386424, 62420258, 62469459, 62531662, 62551356, 62565041, 62584447, 62612266, 62687089, 62690049, 62690909, 62702763, 62724739, 62022345, 62024978, 62104374, 62124040, 62134006, 62200223, 62200224, 62233921, 62294595, 62314725, 62385328, 62436479, 62511942, 62544381, 62565042, 62597795, 62669933, 62696869, 62710618, 62736059, 62768447, 62043559, 62104415, 62121530, 62203396, 62203397, 62314728, 62314730, 62356529, 62390841, 62442847, 62511926, 62551396, 62565057, 62595859, 62654933, 62656069, 62720226, 62034569, 62055683, 62113088, 62130978, 62149714, 62165547, 62168384, 62177253, 62184260, 62256284, 62256285, 62397161, 62420223, 62511956, 62551402, 62565108, 62601570, 62696376, 62742762, 62756031, 62043561, 62055684, 62116593, 62145793, 62152728, 62166195, 62166196, 62168385, 62184261, 62239294, 62319851, 62320878, 62356546, 62390865, 62474905, 62538415, 62565044, 62581863, 62622558, 62632819, 62740693, 62398035, 62440437, 62515479, 62515499, 62563803, 62581853, 62675491, 62059520, 62079725, 62113046, 62144799, 62188423, 62188424, 62188425, 62290837, 62386431, 62436425, 62544361, 62564334, 62601567, 62669897, 62703452, 62742764, 62745001, 62059521, 62064136, 62079726, 62087046, 62104427, 62147239, 62189345, 62189346, 62189347, 62290841, 62351309, 62386782, 62442789, 62469458, 62525501, 62565090, 62565091, 62584448, 62595856, 62656017, 62689230, 62695893, 62710607, 62067441, 62104432, 62130980, 62177257, 62196631, 62196634, 62196637, 62315142, 62315143, 62386432, 62391240, 62442839, 62538411, 62564342, 62581858, 62624335, 62656070, 62686197, 62690916, 62695894, 62710620, 62059522, 62083318, 62104437, 62144801, 62156320, 62161539, 62162598, 62177259, 62239307, 62305411, 62391118, 62469434, 62544379, 62565031, 62595852, 62646287, 62686191, 62686296, 62709061, 62710631, 62746199, 62059523, 62104441, 62145794, 62152729, 62193852, 62193853, 62193854, 62290762, 62356651, 62386783, 62474908, 62531663, 62581867, 62601565, 62632632, 62663173, 62696858, 62697499, 62703451, 62759777, 62055688, 62104442, 62138319, 62187332, 62192904, 62192905, 62201541, 62290838, 62386784, 62436477, 62474904, 62531660, 62565036, 62581860, 62630286, 62658515, 62736051, 62751903, 62059524, 62062241, 62104443, 62138320, 62158149, 62158150, 62162599, 62177261, 62239308, 62255875, 62442842, 62511934, 62551335, 62564347, 62564351, 62624333, 62669906, 62696854, 62696855, 62732175, 62398036, 62440436, 62516039, 62563805, 62648144, and 62704599.
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
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.