Devices

Zimmer

  • Modelo / Serial
    00588605310 TM LPS TIB SZ 3 C/D, 10MM 61776840 61770817 61785352 61792636 61814243 61833815 61844337 61844340 61844341 00588605312 TM LPS TIB SZ 3 C/D, 12MM 61746696 61770813 61785354 61797196 61851748 00588605314 TM LPS TIB SZ 3 C/D, 14MM 61759785 61770812 61797197 00588605317 TM LPS TIB SZ 3 C/D, 17MM 61746694 61759789 61785353 00588605410 TM LPS TIB SZ 4 C/D, 10MM 61733406 61803955 61808992 61833823 61839387 61839369 00588605412 TM LPS TIB SZ 4 C/D, 12MM 61733410 61844343 00588605414 TM LPS TIB SZ 4 C/D, 14MM 61759795 61803956 00588605510 TM LPS TIB SZ 5 E/F, 10MM 61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226 00588605512 TM LPS TIB SZ 5 E/F, 12MM 61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227 00588605514 TM LPS TIB SZ 5 E/F, 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F, 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755  00588605612 TM LPS TIB SZ 6 E/F, 12MM 61759777 61769563 61770836 61785383 61792668 61809022 61844375 00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357 00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646  00588605510 TM LPS TIB SZ 5 E/F 10 MM   61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226  00588605512 TM LPS TIB SZ 5 E/F, 12MM  61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227  00588605514 TM LPS TIB SZ 5 E/F, 14MM  61746717 61770829 61785372 61792662  00588605517 TM LPS TIB SZ 5 E/F, 17MM  61746718 61770828 61809007  00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755  00588605612 TM LPS TIB SZ 6 E/F, 12 mm 61759777 61769563 61770836 61785383 61792668 61809022 61844375  00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357  00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Foreign.
  • Descripción del producto
    TM LPS TIB SZ 3 C/D, 10MM - 00588605310 || TM LPS TIB SZ 3 C/D, 12MM - 00588605312 || TM LPS TIB SZ 3 C/D, 14MM - 00588605314 || TM LPS TIB SZ 3 C/D, 17MM - 00588605317 || TM LPS TIB SZ 4 C/D, 10MM - 00588605410 || TM LPS TIB SZ 4 C/D, 12MM - 00588605412 || TM LPS TIB SZ 4 C/D, 14MM - 00588605414 || TM LPS TIB SZ 5 E/F 10 MM - 00588605510 || TM LPS TIB SZ 5 E/F, 12MM - 00588605512 || TM LPS TIB SZ 5 E/F, 14MM - 00588605514 || TM LPS TIB SZ 5 E/F, 17MM - 00588605517 || TM LPS TIB SZ 6 E/F, 10MM - 00588605610 || TM LPS TIB SZ 6 E/F, 12 mm - 00588605612 || TM LPS TIB SZ 6 E/F, 17MM - 00588605617 || TM LPS TIB SZ 7 G/H, 10MM - 00588605710 || TM LPS TIB SZ 7 G/H, 12MM - 00588605712 || TM LPS TIB SZ 7 G/H, 14MM - 00588605714 || TM LPS TIB SZ 8 G/H, 10MM - 00588605810 || TM LPS TIB SZ 8 G/H, 12MM - 00588605812 || TM LPS TIB SZ 8 G/H, 14MM - 00588605814 || TM LPS TIB SZ 8 G/H, 14MM - 00588605814 || TM LPS TIB SZ 8 G/H, 17MM - 00588605817 || TM LPS TIB SZ 3 E/F, 10MM - 00588606310 || TM LPS TIB SZ 3 E/F, 12MM - 00588606312 || TM LPS TIB SZ 3 E/F, 14MM - 00588606314 || TM LPS TIB SZ 3 E/F, 17MM - 00588606317 || TM LPS TIB SZ 4 E/F, 10MM - 00588606410 || TM LPS TIB SZ 4 E/F, 12MM -00588606412 || TM LPS TIB SZ 4 E/F, 14MM - 00588606414
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.
  • 1 Event

Fabricante

Zimmer Trabecular Metal Technology, Inc.
  • Dirección del fabricante
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 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

645 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Zimmer Air Dermatome II Handpiece Loaner
  • 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
    General and Plastic Surgery Devices
  • 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
    Zimmer Surgical Inc
Device Recall Zimmer Biomet Spine
  • Modelo / Serial
  • Clasificación del producto
    Orthopedic Devices
  • 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
    Zimmer Trabecular Metal Technology, Inc.
Device Recall Zimmer Biomet
  • 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
    Zimmer Biomet, Inc.
Device Recall Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation
  • Modelo / Serial
    Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.
  • Clasificación del producto
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
Device Recall Zimmer Periarticular Locking Plate System
  • Modelo / Serial
    Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • 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 Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
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