Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    Item numbers: 734028800  Lot #'s:  61487614
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • 제품 설명
    Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 제조사 모회사 (2017)
  • 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 263 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    All lots in distribution prior to 5/8/17
  • 유통
    Nationwide Worldwide
  • 제품 설명
    Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
  • Manufacturer
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