FDAFDA · Alimentos y medicamentos·N.º oficial Z-2576-2014
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.
Publicado el 10 de septiembre de 2014 · Inicio del retiro: 7 de agosto de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- 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.
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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