Device Recall Zimmer

  • Modelo / Serial
    lot no.: 61929352 61602065 61800233 61881344 61897089 61958884 61958885 61958886 61993617 62042512 62043576 62137020 62137021 62137022 62224312 61564745 61564747 61657666 61664936 61664937 61764346 61764347 61817406 61817407 61817408 61817409 61839143 61839144 61839145 61881305 61881306 61881307 61881322 61885590 61885592 61885593 61885594 61897083 61897084 61908110 61908114 61908115 61908116 61940081 61940086 61940088 61940090 61940092 61940093 61958887 61958888 61982446 61982447 62020899 62020900 62020901 62038717 62038721 62093613 62093615 62093617 62137023 62137024 62137025 62188625 62188626 62188627 61564754 61800242 61800243 61800244 61800245 61800251 61804379 61839148 61839149 61843698 61881323 61881328 61885595 61885596 61885598 61897085 61897086 61926555 61926556 61926558 61952708 61952709 61952710 61952711 61958889 61958890 61958891 61958892 61958893 61968087 61968088 61968090 62015514 62015520 62020902 62020903 62042513 62043577 62093623 62137026 62137028 62137029 62142069 62142072 62188628 62188629 62188638 62188640 62188643 61764348 61764349 61885603 61885605 61897087 61978180 61978181 61978182 61993618 62042514 62043578 62137030 62137032 61657688 61929353 61978183 61978184 62038740 62038741 62112767 62112769 61993622 62165490 61915262 61915263 61915264 62056670 62056673 62056674 62056675 62056676 62056677 62056678 62056679 62056680 62056681 62056682 62056683 62056684 62056685 62056686 62121124 62121125 62121126 62142063 62224315 62224317 62224320 62224321 62224322 62298604 61929356 61929357 62067205 62067217 62067222 62067225 62067228 62067229 62067241 62067242 62067244 62067245 62067246 62067253 62067255 62067257 62121153 62121154 62121155 62121156 62224328 62224329 62224330 62224331 62237601 62237605 62262081 62262081N 61993624 61915268 61915269 61915270 62130479 62130485 62130492 62130496 62130510 62130723 62130724 62130725 62130726 62137033 62137034 62237282 62237285 62237288 62237289 62237291 62237294 61993628 61915272 61915273 61915274 61915275 62129873 62129874 62129875 62129876 62129877 62129878 62129879 62129881 62137038 62165497 61915276 61915277
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 36 consists of all product under product code: HSB and same usage: || Item no: || 225302745 INTERLOCKING IM SCREW 4.5 || 225303045 INTERLOCKING IM SCREW 4.5 || 225303245 INTERLOCKING IM SCREW 4.5 || 225303545 INTERLOCKING IM SCREW 4.5 || 225303745 INTERLOCKING IM SCREW 4.5 || 225304045 INTERLOCKING IM SCREW 4.5 || 225304245 INTERLOCKING IM SCREW 4.5 || 225304545 INTERLOCKING IM SCREW 4.5 || 225305045 INTERLOCKING IM SCREW 4.5 || 225305245 INTERLOCKING IM SCREW 4.5 || 225305545 INTERLOCKING IM SCREW 4.5 || 225305745 INTERLOCKING IM SCREW 4.5 || 225306045 INTERLOCKING IM SCREW 4.5 || 225306545 INTERLOCKING IM SCREW 4.5 || 225307045 INTERLOCKING IM SCREW 4.5 || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Empresa matriz del fabricante (2017)
  • 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

  • Modelo / Serial
    Lot # 61977101, Serial # 500001  500019 Lot # 61980678, Serial # 500021  500040 Lot # 61989398, Serial # 500081  500090 Lot # 62008619, Serial # 500091  500110 Lot # 62083340, Serial # 500151  500170 Lot # 62096333, Serial # 500171  500190 Lot # 62122378, Serial # 500191  500210 Lot # 62191658, Serial # 500211  500230 Lot # 62191665, Serial # 500231  500250 Lot # 62220857, Serial # 500251  500270 Lot # 62220882, Serial # 500291  500310 Lot # 62244236, Serial # 500331  500350 Lot # 62266024, Serial # 500351  500371 Lot # 62267510, Serial # 500372  500391 Lot # 62267596, Serial # 500452  500471 Lot # 62289834, Serial # 500412  500431 Lot # 62309628, Serial # 500472  500491 Lot # 62309698, Serial # 500512  500531 Lot # 62369392, Serial # 500532  500551 Lot # 62374685, Serial # 500552  500571 Lot # 62374721, Serial # 500592  500611 Lot # 62393971, Serial # 500632  500651 Lot # 62394012, Serial # 500652  500671 Lot # 62454338, Serial # 500692  500711 Lot # 62476761, Serial # 500712  500731 Lot # 62494048, Serial # 500732  500751 Lot # 62494086, Serial # 500752  500771 Lot # 62525837, Serial # 500772  500791 Lot # 62554526, Serial # 500792  500811 Lot # 62578715, Serial # 500812  500831 Lot # 62578759, Serial # 500832  500851 Lot # 62635778, Serial # 500852  500871
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
  • Descripción del producto
    Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. || The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. || The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
  • Manufacturer
  • Modelo / Serial
    There are no lot code(s) for the 01-8851-001-00 loaner part number due to when the device is physically manufactured, it is done so as part number 00-8851-001-00 and lot codes are assigned to this part number. The 01-8851-001-00 exists in order to differentiate that the device is being distributed as a loaner rather than a sale of the device
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
  • Descripción del producto
    Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.
  • Manufacturer
  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
  • Manufacturer
  • Modelo / Serial
    All lots in distribution prior to 5/8/17
  • Distribución
    Nationwide Worldwide
  • Descripción del producto
    Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Descripción del producto
    Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
  • Manufacturer
258 más