Devices

Device Recall EndobonXenograft Granules

  • 모델명 / 제조번호(시리얼번호)
    Item Numbers &Lot; Numbers: ROX05 S016303 ROX05 S016304 ROX05 S0163056 ROX05 S0163059 ROX05 S0171051 ROX05 S017105R ROX05 S0171098 ROX05 T0001122 ROX05 T0001133 ROX05 T0001136 ROX05 T0001141 ROX05 T0001147 ROX05 T0025073 ROX05 T0034084 ROX05 T0045150 ROX05 T0045157 ROX05 T0052108 ROX05 T0064164 ROX05 T0064168 ROX05 T0064175 ROX05 T0096191 ROX05 T0104217 ROX05 T0104238 ROX05 T0114238 ROX05 T0122226 ROX05 T0122238 ROX05 T0134261 ROX05 T0134269 ROX05 T0142245 ROX05 T0142248 ROX05 T0162294 ROX05 T0183280 ROX05 T0192311 ROX05 T0192316 ROX05 T0205297 ROX05 T0214319 ROX05 T0224329 ROX05 T0224333 ROX05 T0224338 ROX05 T0224346 ROX05 T0224357 ROX05 T0234357 ROX05 T0245006 ROX05 T0245009 ROX05 T0254015 ROX05 T0266030 ROX05 T0273037 ROX05 T0273051 ROX05 T0281043 ROX05 T0281065 ROX05 T0281078 ROX05 T0291099 ROX05 T0291106 ROX05 T0291118 ROX05 T0291125 ROX05 T0291134 ROX05 U0013175 ROX05 U0025142 ROX05 U0025170 ROX05 U0035175 ROX05 U0055155 ROX05 U0055170 ROX05 U0084189 ROX05 U0084209 ROX05 U0092202 ROX05 U0092237 ROX05 U0102265 ROX05 U0114279 ROX05 U0124272 ROX05 U0132289 ROX05 U0132307 ROX05 U0132316 ROX05 U0141251 ROX05 U0141254 ROX05 U0141265 ROX05 U0153300 ROX05 U0171316 ROX05 U0181349 ROX05 U0193328 ROX05 U0193349 ROX05 U0201005 ROX05 U0201019 ROX05 U0201337 ROX05 U0201349 ROX05 U0213019 ROX05 U0213040 ROX05 U0242047 ROX05 U0253061 ROX05 U0253068 ROX05 U0253075 ROX05 U0253082 ROX05 U0253089 ROX05 U0253138 ROX05 U0261131 ROX05 U0261148 ROX05 U0261159 ROX05 V0021138 ROX05 V0021176 ROX05 V0034194 ROX05 V0044201 ROX05 V0044208 ROX05 V0044239 ROX05 V0051267 ROX05 V0082187 ROX10 S0171056 ROX10 S0171065 ROX10 S0171108 ROX10 T0001119 ROX10 T0001122 ROX10 T0001133 ROX10 T0001136 ROX10 T0001141 ROX10 T0001147 ROX10 T0025073 ROX10 T0025098 ROX10 T0034084 ROX10 T0045150 ROX10 T0045157 ROX10 T0052108 ROX10 T0064168 ROX10 T0074175 ROX10 T0074179 ROX10 T0084189 ROX10 T0096191 ROX10 T0104217 ROX10 T0114238 ROX10 T0134261 ROX10 T0142248 ROX10 T0142254 ROX10 T0162294 ROX10 T0183280 ROX10 T0192311 ROX10 T0192316 ROX10 T0205297 ROX10 T0214319 ROX10 T0234357 ROX10 T0245006 ROX10 T0245020 ROX10 T0254015 ROX10 T0254051 ROX10 T0266030 ROX10 T0273037 ROX10 T0281043 ROX10 T0281062 ROX10 T0281065 ROX10 T0281071 ROX10 T0291078 ROX10 T0291125 ROX10 T0291170 ROX10 T0304134 ROX10 T0304170 ROX10 U0035142 ROX10 U0035155 ROX10 U0035237 ROX10 U0073170 ROX10 U0084189 ROX10 U0092202 ROX10 U0102251 ROX10 U0114279 ROX10 U0114286 ROX10 U0114307 ROX10 U0124265 ROX10 U0124272 ROX10 U0141254 ROX10 U0153300 ROX10 U0171316 ROX10 U0193328 ROX10 U0201005 ROX10 U0201337 ROX10 U0201349 ROX10 U0213026 ROX10 U0223026 ROX10 U0234054 ROX10 U0234061 ROX10 U0242040 ROX10 U0253082 ROX10 U0253089 ROX10 U0261124 ROX10 V0021138 ROX10 V0021148 ROX10 V0021168 ROX10 V0044194 ROX10 V0044208 ROX10 V0082187 ROX20 T0001119 ROX20 T0001133 ROX20 T0001150 ROX20 T0025098 ROX20 T0052108 ROX20 T0064164 ROX20 T0074157 ROX20 T0074175 ROX20 T0074189 ROX20 T0096191 ROX20 T0104217 ROX20 T0134261 ROX20 T0183280 ROX20 T0192311 ROX20 T0205297 ROX20 T0224338 ROX20 T0224346 ROX20 T0234357 ROX20 T0245006 ROX20 T0245009 ROX20 T0254015 ROX20 T0254024 ROX20 T0266030 ROX20 T0273037 ROX20 T0273051 ROX20 T0281043 ROX20 T0281065 ROX20 T0281078 ROX20 T0281093 ROX20 T0291099 ROX20 T0291106 ROX20 T0304125 ROX20 T0304155 ROX20 U0013142 ROX20 U0013170 ROX20 U0055142 ROX20 U0092189 ROX20 U0092202 ROX20 U0092254 ROX20 U0114279 ROX20 U0124265 ROX20 U0132307 ROX20 U0141251 ROX20 U0153300 ROX20 U0193328 ROX20 U0201349 ROX20 U0234061 ROX20 U0253082 ROX20 U0261106 ROX20 U0261138 ROX20 V0021148 ROX20 V0034187 ROX20 V0034194 ROX20 V0044208 ROXLG20 T0002136 ROXLG20 T0002141 ROXLG20 T0002150 ROXLG20 T0002157 ROXLG20 T0002164 ROXLG20 T0035065 ROXLG20 T0035073 ROXLG20 T0035084 ROXLG20 T0035098 ROXLG20 T0065191 ROXLG20 T0085238 ROXLG20 T0135294 ROXLG20 T0143259 ROXLG20 T0143308 ROXLG20 T0143319 ROXLG20 T0215006 ROXLG20 T0215015 ROXLG20 T0235357 ROXLG20 T0274024 ROXLG20 T0282051 ROXLG20 T0292062 ROXLG20 T0305093 ROXLG20 U0014099 ROXLG20 U0014125 ROXLG20 U0024106 ROXLG20 U0034142 ROXLG20 U0044134 ROXLG20 U0044155 ROXLG20 U0103202 ROXLG20 U0125260 ROXLG20 U0125265 ROXLG20 U0142209 ROXLG20 U0194330 ROXLG20 U0262075 ROXLG20 V0035097 ROXLG20 V0045120 ROXLG20 V0052106 ROXLG20 V0064138 ROXLG20 V0073176 ROXLG20 V0091159 ROXLG20 V0112168 ROXLG50 S017204 ROXLG50 T0026056 ROXLG50 T0044179 ROXLG50 T0044189 ROXLG50 T0044259 ROXLG50 T0044287 ROXLG50 T0053133 ROXLG50 T0065238 ROXLG50 T0075191 ROXLG50 T0075287 ROXLG50 T0143311 ROXLG50 T0193333 ROXLG50 T0193357 ROXLG50 T0206338 ROXLG50 T0215037 ROXLG50 T0235346 ROXLG50 T0274024 ROXLG50 T0282034 ROXLG50 T0282043 ROXLG50 T0282051 ROXLG50 U0014125 ROXLG50 U0014134 ROXLG50 U0034155 ROXLG50 U0044142 ROXLG50 U0044155 ROXLG50 U0091189 ROXLG50 U0115260 ROXLG50 U0142209 ROXLG50 U0172286 ROXLG50 U0224005 ROXLG50 U0262075 ROXLG50 V0045120 ROXLG50 V0052106 ROXLG50 V0052131 ROXLG50 V0064141 ROXLG50 V0091159 ROXLG50 V0112194 ROXLG80 S017204 ROXLG80 T0002150 ROXLG80 T0002157 ROXLG80 T0002164 ROXLG80 T0026056 ROXLG80 T0044175 ROXLG80 T0053108 ROXLG80 T0053122 ROXLG80 T0065238 ROXLG80 T0097191 ROXLG80 T0097238 ROXLG80 T0115238 ROXLG80 T0125261 ROXLG80 T0135269 ROXLG80 T0135294 ROXLG80 T0163316 ROXLG80 T0193333 ROXLG80 T0206338 ROXLG80 T0215006 ROXLG80 T0215346 ROXLG80 T0255006 ROXLG80 T0264020 ROXLG80 T0274024 ROXLG80 T0282034 ROXLG80 T0292043 ROXLG80 T0292065 ROXLG80 T0292085 ROXLG80 T0305071 ROXLG80 T0305078 ROXLG80 T0305093 ROXLG80 U0024106 ROXLG80 U0034125 ROXLG80 U0054142 ROXLG80 U0054155 ROXLG80 U0074170 ROXLG80 U0085189 ROXLG80 U0091189 ROXLG80 U0115260 ROXLG80 U0142209 ROXLG80 U0154286 ROXLG80 U0172289 ROXLG80 U0182307 ROXLG80 U0202337 ROXLG80 U0202349 ROXLG80 U0214342 ROXLG80 U0214349 ROXLG80 U0224026 ROXLG80 U0233047 ROXLG80 U0243040 ROXLG80 U0254061 ROXLG80 U0262075 ROXLG80 V0022082 ROXLG80 V0035097 ROXLG80 V0045120 ROXLG80 V0052117 ROXLG80 V0073176 ROXLG80 V0083141 ROXLG80 V0091159 ROXLG80 V0112194 ROXLG80 V0134208 ROXLG80 V0143230 ROXLG80 V0161208
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including AL, AK, AR, AK, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Japan, Europe.
  • 제품 설명
    Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. || Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.
  • Manufacturer
    Biomet France SARL
  • 1 Event

제조사

Biomet France SARL
  • 제조사 주소
    Biomet France SARL, Plateau de Lautagne, Valence Cedex 9 France
  • 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