Devices

Device Recall Endosseous Dental Implant

  • 모델명 / 제조번호(시리얼번호)
    lot # 63196608, 63224322, 63260962, 63327428, 63327427, 63346417, 63355661, 63355664, 63355665, 63376660, 63376662, 63376661, 63376663, 63395410, 63395405, 63395406, 63395407, 63395404, 63406219, 63406221, 63419209, 63419210, 63456331, 63456332, 63465599, 63466907, 63466908, 63474628, 63477075, 63488535, 63484450, 63488536, 63497308, 63497305, 63497307, 63510220, 63525249, 63525250, 63530399, 63529116, 63556373, 63561213, 63231611, 63232148, 63235422, 63260202, 63260203, 63346423, 63346421, 63356678, 63356675, 63376655, 63376657, 63376654, 63376653, 63376656, 63395415, 63395413, 63395414, 63403215, 63406224, 63406223, 63423431, 63447115, 63493319, 63493321, 63493320, 63497313, 63497311, 63494469, 63497310, 63497315, 63503047, 63510221, 63514475, 63517534, 63556374, 61286832, 62665080, 63193089, 63284657, 63355672, 63376713, 63395418, 63401354, 63412145, 63456336, 63474629, 63505401, 62591831, 63327432, 63376658, 63395428, 63447117, 63456337, 63517538, 63556375, 62644526, 63193906, 63232146, 63284601
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • 제품 설명
    ABUT GOLD FRICTION-FIT, REF HLA3G; || ABUT GOLD FRICTION-FIT, REF HLA4G; || COPING GOLD ENG 5.7 MM, REF HLA5G; || COPING GOLD NON-ENG. 3.5, REF NEA3G; || COPING GOLD NON-ENG. 4.5, REF NEA4G
  • Manufacturer
    Zimmer Dental Inc
  • 1 Event

제조사

Zimmer Dental Inc
  • 제조사 주소
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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 6 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Endosseous Dental Implant Accessories
  • 모델명 / 제조번호(시리얼번호)
    lot # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, 63503028
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • 제품 설명
    Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
  • Manufacturer
    Zimmer Dental Inc
Device Recall Endosseous Dental Implant Accessories
  • 모델명 / 제조번호(시리얼번호)
    lot # 63145351, 63202941, 60646055, 62353334, 63316134
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • 제품 설명
    TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; || TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; || TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; || TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
  • Manufacturer
    Zimmer Dental Inc
Device Recall Endosseous Dental Implant Accessories
  • 모델명 / 제조번호(시리얼번호)
    lot # 63275811, 63238369, 63286562, 63240994, 63250273, 63286560, 62556219, 62607124, 62675252, 62445681, 62086170, 62679151, 62734003
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • 제품 설명
    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; || MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; || IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; || IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; || IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; || IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; || MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; || IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S
  • Manufacturer
    Zimmer Dental Inc
Device Recall Endosseous Dental Implant Accessories
  • 모델명 / 제조번호(시리얼번호)
    lot # 62625167 63254074 63455622 63155008 63331292 63432495 63152070 63209557 63254047 62602470 63135399 63240239 63254023 61722820 62593186 62635420 63254006
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • 제품 설명
    WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; || WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; || WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; || WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; || WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; || WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; || WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; || WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S
  • Manufacturer
    Zimmer Dental Inc
Device Recall Endosseous Dental Implant
  • 모델명 / 제조번호(시리얼번호)
    lot # 63234403, 62358420, 62899483, 63542012, 63220769, 61378631, 62899245, 63409322, 61268685, 62358417, 63091159, 63110269, 63522662, 63529122, 60807237, 62367536, 63471081
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • 제품 설명
    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; || IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; || IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; || IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; || IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; || IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
  • Manufacturer
    Zimmer Dental Inc
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