Devices

Zimmer

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide and Foreign.
  • 제품 설명
    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

제조사

Zimmer Trabecular Metal Technology, Inc.
  • 제조사 주소
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 645 건

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Device Recall Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 00-2258-051-01; Lot No. 53951300; Manufactured 8/8/2002
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain.
  • 제품 설명
    Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE || Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer Trabecular Metal" Femoral Cone Augment
  • 모델명 / 제조번호(시리얼번호)
    Lot: 60683028, Manufactured: 6/05/2007
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.
  • 제품 설명
    TRABECULAR METAL ¿ FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. || The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer Trabecular Metal" Femoral Cone Augment
  • 모델명 / 제조번호(시리얼번호)
    Lot: 60683036, Manufactured: 6/07/2007
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.
  • 제품 설명
    TRABECULAR METAL ¿ FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32. || The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
  • Manufacturer
    Zimmer Inc.
Zimmer Trabecular Metal Modular Acetabular System
  • 모델명 / 제조번호(시리얼번호)
    Part 00-6202-052-21, Lot 61132698 and lot 001122467
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.
  • 제품 설명
    The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. || The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.
  • Manufacturer
    Zimmer Inc.
zimmer Anatomical Shoulder Glenoid S
  • 모델명 / 제조번호(시리얼번호)
    REF Numbers: 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405. Lot 2416527, 2430357, 2447460, 2450204, 2348311, 2348311, 2364768, 2364768, 2364768, 2403597, 2418592, 2418592, 2452946, 2453947, 2503319, 2503319, 2517200, 2329832, 2349655, 2388161, 2453280, 2453280, and 2533474.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 || PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, || Glenoid M, cemented, sterile; REF 01.04214.370, || Glenoid L, cemented, sterile; REF 01.04214.400 || PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405
  • Manufacturer
    Zimmer, Inc.
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