FDAFDA · Alimentos y medicamentos·N.º oficial Z-0521-2014
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
Publicado el 25 de diciembre de 2013 · Inicio del retiro: 15 de noviembre de 2013
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
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Intuitive Surgical, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.
- Lote
- Part number 400006 on da Vinci IS1200; Lot numbers: 710182 801282 805131 M10080716 M10080910 M10090216 M10091104 M10100728 S10080613 710192 802042 805221 M10080718 M10081014 M10090225 M10091110 M10100729 S10080618 710262 802052 805271 M10080721 M10081024 M10090325 M10091113 M10100804 S10080624 710301 802061 910072 M10080722 M10081027 M10090325 M10091120 M10100810 S10080626 710302 802072 1610072 M10080723 M10081028 M10090401 M10091130 M10100813 S10080708 711052 802082 M10080603 M10080724 M10081029 M10090407 M10091209 M10100820 S10080709 711062 802122 M10080603 M10080725 M10081031 M10090415 M10091211 M10100902 S10080711 711072 802131 M10080603 M10080728 M10081104 M10090417 M10091214 M10100924 S10080712 711082 802152 M10080605 M10080729 M10081110 M10090427 M10091216 M10100927 S10080715 711092 802202 M10080606 M10080730 M10081111 M10090505 M10100113 M10100929 S10080718 711122 802212 M10080609 M10080731 M10081112 M10090514 M10100118 M10101026 711142 802252 M10080610 M10080801 M10081117 M10090519 M10100123 M10101103 711152 802262 M10080612 M10080804 M10081119 M10090521 M10100128 M10101118 711262 802272 M10080616 M10080805 M10081120 M10090526 M10100129 M10101123 711282 803042 M10080617 M10080806 M10081124 M10090604 M10100209 M10101124 711302 803101 M10080618 M10080807 M10081125 M10090605 M10100212 M10101209 712042 803112 M10080618 M10080808 M10081127 M10090616 M10100222 M10110113 712062 803132 M10080618 M10080811 M10081128 M10090704 M10100225 M10110131 712102 803172 M10080619 M10080812 M10081201 M10090713 M10100302 M10110208 712112 803192 M10080620 M10080813 M10081204 M10090717 M10100308 M10110210 712142 803212 M10080623 M10080814 M10081205 M10090728 M10100312 M10110217 712182 803241 M10080624 M10080815 M10081209 M10090810 M10100323 M10110224 712192 803261 M10080625 M10080818 M10081210 M10090811 M10100326 M10110304 712212 803271 M10080626 M10080819 M10081211 M10090817 M10100408 M10110310 801021 804081 M10080627 M10080820 M10081218 M10090826 M10100430 M10110317 801072 804101 M10080630 M10080821 M10090107 M10090901 M10100506 M10110323 801092 804121 M10080701 M10080825 M10090112 M10090905 M10100507 M10110419 801142 804171 M10080702 M10080828 M10090115 M10090911 M10100511 M10110506 801152 804221 M10080704 M10080901 M10090127 M10090922 M10100518 M10110523 801171 804231 M10080707 M10080902 M10090127 M10091001 M10100601 S10080603 801212 804241 M10080708 M10080903 M10090128 M10091002 M10100602 S10080606 801222 804261 M10080709 M10080904 M10090203 M10091015 M10100607 S10080606 801242 804291 M10080710 M10080905 M10090205 M10091027 M10100625 S10080612 801252 805071 M10080711 M10080909 M10090209 M10091102 M10100722 S10080612; Part number 420006 used on IS2000: lot numbers: 610072 801252 804221 M10080624 M10080815 M10081020 M10081219 M10090501 M10090813 M10091209 S10080702 710222 801282 804231 M10080624 M10080818 M10081021 M10081222 M10090504 M10090814 M10091210 S10080705 710242 801302 804241 M10080624 M10080819 M10081022 M10081223 M10090509 M10090820 M10091211 S10080705 711052 802042 804291 M10080625 M10080820 M10081023 M10090105 M10090511 M10090821 M10091212 S10080707 711062 802052 805051 M10080626 M10080821 M10081024 M10090106 M10090513 M10090831 M10091215 S10080710 711072 802072 805091 M10080703 M10080822 M10081028 M10090109 M10090514 M10090901 M10091217 S10080714 711082 802082 805121 M10080704 M10080825 M10081029 M10090116 M10090519 M10090905 M10091218 S10080715 711092 802131 805171 M10080707 M10080827 M10081030 M10090119 M10090520 M10090907 M10091221 S10080717 711122 802142 805201 M10080708 M10080828 M10081031 M10090122 M10090521 M10090909 M10100104 S10081120 711
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.