Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2576-2014)
See the recall detail below. You can also see other recalls from the same firm in 2014.
PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.
Class II
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.
Part Numbers: 42517600410, 42517600510, 42517600610, 42517600710, 42517600810, 42517600910, 42517601010, 42517601110, 42527600410, 42527600510, 42527600610, 42527600710, 42527600810, 42527600910, 42527601010, and 42527601110. Lot numbers: 62342526, 62423918, 62423919, 62423920, 62427414, 62482212, 62563745, 62612225, 62656072, 62740698, 62342527, 62405895, 62430401, 62504179, 62511925, 62563784, 62638665, 62695870, 62343066, 62406967, 62432146, 62515486, 62564324, 62691390, 62717335, 62351291, 62374838, 62415307, 62430397, 62518138, 62622527, 62696875, 62357867, 62374796, 62427836, 62441229, 62511924, 62563908, 62565948, 62590523, 62695295, 62361315, 62376662, 62420192, 62434748, 62518137, 62540059, 62563778, 62627131, 62698733, 62363684, 62367078, 62423914, 62430398, 62494662, 62565936, 62658602, 62695876, 62445930, 62340579, 62344051, 62423923, 62423924, 62423925, 62423926, 62482213, 62563747, 62610937, 62710619, 62342528, 62405897, 62434390, 62515483, 62563726, 62612227, 62695297, 62349892, 62422726, 62434393, 62515488, 62563788, 62631075, 62698741, 62355455, 62374809, 62421505, 62434752, 62522772, 62602612, 62695290, 62717336, 62368460, 62374671, 62415303, 62435709, 62435710, 62435711, 62505567, 62563909, 62565944, 62691386, 62360467, 62374806, 62422729, 62434754, 62504020, 62630275, 62691388, 62698735, 62368463, 62374824, 62423915, 62435712, 62435713, 62499165, 62563927, 62565963, 62446275, and 62502226.
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.
Voluntary: Firm initiated