Devices

Device Recall Zimmer

  • Modelo / Serial
    lot no.: 61982436 61867365 61886667 61886668 61820722 61897702 61977095 61799436 61934575 61828057 61982437 61828048 61934576 61798403 61906719 62031688 62197641 61663372 61828049 61886669 61828050 62031689 61828053 62106374 61828054 62033051 62197643 61828055 61906715 61982438 61867334 61977096 61927725 61784953 61867368 61849821 61849827 61906712 62124274 62120943 61785930 61771006 61826981 61895080 61902197 61827363 61888704 61895083 62255904 61902213 61990124 61753044 62271887 61850459 61778818 61778840 61827350 61827352 61827355 61853069 61865454 61865455 61888705 61895087 61897708 61897709 61897711 61900062 61941016 61941017 61958817 61990133 62127925 62130793 62130794 62241680 62255912 62255914 62255920 62271894 61902217 61958146 62271889 61958147 61955869 62105421 61860644 61888706 61937605 370531 61853081 61870427 62230186 61777469 61923868 61940612 61940613 370989 61853082 61955870 61890945 61930189 61859417 61923869 61788809 61829108 370516 61860640 61874946 370515 370959 370956 61843251 61937601 62105422 371015 61895079 61788813 61849271 371014 370517 61860668 61869716 61874978 370990 370923 61891507 371071 61902208 370955
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 30 consists of all product under product code: KTT and same usage: || Item no: || 118100527 FREE-LOCK LAG SCREW, 12.7 || 118100535 FREE-LOCK LAG SCREW, 12.7 || 118100540 FREE-LOCK LAG SCREW, 12.7 || 118100542 FREE-LOCK LAG SCREW, 12.7 || 118101022 FREE-LOCK LAG SCREW, 12.7 || 118101025 FREE-LOCK LAG SCREW, 12.7 || 118101027 FREE-LOCK LAG SCREW, 12.7 || 118101030 FREE-LOCK LAG SCREW, 12.7 || 118101032 FREE-LOCK LAG SCREW, 12.7 || 118101035 FREE-LOCK LAG SCREW, 12.7 || 118101037 FREE-LOCK LAG SCREW, 12.7 || 118101040 FREE-LOCK LAG SCREW, 12.7 || 118101042 FREE-LOCK LAG SCREW, 12.7 || 118101045 FREE-LOCK LAG SCREW, 12.7 || 118101047 FREE-LOCK LAG SCREW, 12.7 || 118101052 FREE-LOCK LAG SCREW, 12.7 || 118101055 FREE-LOCK LAG SCREW, 12.7 || 118101057 FREE-LOCK LAG SCREW, 12.7 || 118101522 FREE-LOCK LAG SCREW, 15.8 || 118101525 FREE-LOCK LAG SCREW, 15.8 || 118101527 FREE-LOCK LAG SCREW, 15.8 || 118101530 FREE-LOCK LAG SCREW, 15.8 || 118101532 FREE-LOCK LAG SCREW, 15.8 || 118101547 FREE-LOCK LAG SCREW, 15.8 || 118109010 FREE-LOCK SUPRACOND TUBE/ || 118109510 FREE-LOCK SUPRACOND TUBE/ || 118113005 FREE-LOCK TUBE & SCP PLAT || 118113006 FREE-LOCK TUBE & SCP PLAT || 118113010 FREE-LOCK TUBE & SCP PLAT || 118113504 FREE-LOCK TUBE & SCP PLAT || 118113505 FREE-LOCK TUBE & SCP PLAT || 118113506 FREE-LOCK TUBE & SCP PLAT || 118113508 FREE-LOCK TUBE & SCP PLAT || 118113510 FREE-LOCK TUBE & SCP PLAT || 118113594 FREE-LOCK TUBE & SCP PLAT || 118114005 FREE-LOCK TUBE & SCP PLAT || 118114006 FREE-LOCK TUBE & SCP PLAT || 118114008 FREE-LOCK TUBE & SCP PLAT || 118114010 FREE-LOCK TUBE & SCP PLAT || 118114012 FREE-LOCK TUBE & SCP PLAT || 118114004 FREE-LOCK TUBE & SCP PLAT || 118114008 FREE-LOCK TUBE & SCP PLAT || 118114010 FREE-LOCK TUBE & SCP PLAT || 118114012 FREE-LOCK TUBE & SCP PLAT || 118114504 FREE-LOCK TUBE & SCP PLAT || 118114505 FREE-LOCK TUBE & SCP PLAT || 118114506 FREE-LOCK TUBE & SCP PLAT || 118114508 FREE-LOCK TUBE & SCP PLAT || 118114512 FREE-LOCK TUBE & SCP PLAT || 118114594 FREE-LOCK TUBE & SCP PLAT || 118114508 FREE-LOCK TUBE & SCP PLAT || 118114512 FREE-LOCK TUBE & SCP PLAT || 118114594 FREE-LOCK TUBE & SCP PLAT || 118115004 FREE-LOCK TUBE & SCP PLAT || 118115005 FREE-LOCK TUBE & SCP PLAT || 118115006 FREE-LOCK TUBE & SCP PLAT || 118115008 FREE-LOCK TUBE & SCP PLAT || 118115094 FREE-LOCK TUBE & SCP PLAT || 118113508 FREE-LOCK TUBE & SCP PLAT || 118113506 FREE-LOCK TUBE & SCP PLAT || 118113505 FREE-LOCK TUBE & SCP PLAT || 118113504 FREE-LOCK TUBE & SCP PLAT || 118113004 FREE-LOCK TUBE & SCP PLAT || Product Usage: || Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

Fabricante

Zimmer Manufacturing B.V.
  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

263 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Zimmer Periarticular Locking Plate System, Distal Medial Humeral Locking Plate, Short
  • Modelo / Serial
    Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Internationally Distributed in China only.
  • Descripción del producto
    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM || DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT || RIGHT 11 HOLES 178 MM LENGTH || STERILE RX ONLY || Product Usage: Usage: || The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Unicompartmental Knee Femoral Component
  • Modelo / Serial
    Part Number Range:00-5842-011/017-01/02
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
  • Descripción del producto
    Zimmer¿ Unicompartmental Knee Femoral Component. || Indicated for patients with painful and/or disabling knee joint.
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Periarticular Plating System
  • Modelo / Serial
    Item #'s:  00-2347-001-12 00-2347-001-14 00-2347-001-16 00-2347-001-18 Lot #s: All lots with an expiration date prior to July 24, 2023
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    FEM COND BUTTRESS PLT, RT.
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Periarticular Locking Plate System
  • Modelo / Serial
    Item Numbers:  47-2357-101-14 47-2357-101-18 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    DIST LAT FEM LOCK PLT, RT
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components
  • Modelo / Serial
    Part Number Lot Number 00450001100 62072174 00450001100 62248802 00450001100 62264833 00450001100 62267033 00450001100 62279041 00450001100 62279043 00450001100 62331803 00450001100 62331808 00450001100 62337755 00450001100 62343558 00450001100 62357496 00450001100 62357497 00450001100 62397412 00450001100 62397413 00450001100 62430803 00450001200 11007903 00450001200 11008443 00450001200 62168362 00450001200 62239775 00450001200 62239789 00450001200 62267626 00450001200 62267627 00450001200 62279044 00450001200 62279050 00450001600 62168363 00450001600 62239794 00450001600 62264836 00450001600 62264837 00450001600 62267631 00450001600 62290823 00450001600 62290824 00450001600 62297847 00450001600 62297848 00450001600 62310752 00450001600 62316170 00450001600 62323809 00450001600 62331810 00450001600 62337757 00450001600 62349862 00450001600 62357499 00450001600 62372416 00450001600 62405309 00450001600 62419534 00450001200 62285546 00450001200 62290833 00450001200 62290835 00450001200 62372414 00450001200 62375863 00450001200 62397414 00450001200 62405304 00450001200 62416035 00450001200 62419530 00450001200 62430804 00450001300 62160227 00450001300 62163379 00450001300 62215393 00450001300 62264834 00450001300 62267628 00450001300 62267629 00450001300 62279045 00450001300 62279051 00450001300 62285548 00450001300 62290836 00450001300 62299551 00450001300 62331811 00450001300 62337756 00450001300 62349856 00450001300 62349857 00450001300 62368383 00450001300 62375865 00450001300 62375868 00450001300 62378060 00450001300 62397415 00450001300 62397416 00450001300 62409032 00450001300 62409033 00450001300 62416036 00450001300 62419532 00450001300 62430805 00450001400 11007904 00450001400 11008529 00450001400 62163382 00450001400 62208153 00450001400 62239776 00450001400 62239786 00450001400 62264835 00450001400 62279052 00450001400 62290829 00450001400 62299552 00450001400 62305739 00450001400 62310750 00450001400 62316168 00450001400 62316169 00450001400 62343549 00450001400 62343550 00450001400 62343551 00450001400 62349858 00450001400 62368384 00450001400 62372415 00450001400 62378062 00450001400 62393803 00450001400 62393804 00450001400 62397417 00450001400 62405306 00450001400 62409034 00450001400 62416038 00450001400 62416039 00450001400 62416040 00450001400 62419533 00450001400 62459855 00450001500 62072172 00450001500 62208154 00450001500 62215392 00450001500 62220672 00450001500 62220674 00450001500 62226570 00450001500 62279046 00450001500 62279053 00450001500 62285550 00450001500 62290842 00450001500 62331809 00450001500 62349859 00450001500 62349861 00450001500 62357498 00450001500 62358906 00450001500 62378063 00450001500 62393805 00450001500 62397418 00450001500 62405308 00450001500 62416042 00450001500 62439673 00450001600 11007906 Part Number Lot Number 00830001100 62264850 00830001100 62316172 00830001100 62323776 00830001100 62337212 00830001100 62357509 00830001200 62204729 00830001200 62215395 00830001200 62316173 00830001200 62323778 00830001200 62331816 00830001200 62343559 00830001300 11008422 00830001300 62204730 00830001300 62220676 00830001300 62267038 00830001300 62267040 00830001300 62323781 00830001300 62331817 00830001300 62337216 00830001300 62349869 00830001300 62409040 00830001400 62208150 00830001400 62264851 00830001400 62310756 00830001400 62316177 00830001400 62323783 00830001400 62343560 00830001400 62343561 00830001400 62368388 00830001500 62204731 00830001500 62215396 00830001500 62305743 00830001500 62323784 00830001500 62343563 00830001500 62357510 00830001500 62428994 00830001600 62264852 00830001600 62299553 00830001600 62316174 00830001600 62323786 00830001600 62337210 00830001600 62343565 00830001600 62357511
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • Descripción del producto
    Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 || Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.
  • Manufacturer
    Zimmer, Inc.
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