Device Recall Biovent

  • Modelo / Serial
    BioVent Implant Line   Part # Description Lot Number Quantity BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 014528 294 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 017357 81 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 017725 89 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 02000087 196 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 014684 112 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 016795 89 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 017488 90 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 0200201 93 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 013178 300 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 014531 382 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 017726 51 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 0200685 96 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 0200861 243 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 012359 87 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 013829 98 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 015111 99 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 016955 85 BV16 Imp, Bio-Vent, HA, 3.5mm, 16mm 017703 50 BV16 Imp, Bio-Vent, HA, 3.5mm, 16mm 0200088 94 BV8 IMPLANT,BIO-VENT,INT HEX,HA,8MM L 012855 41 BV8 IMPLANT,BIO-VENT,INT HEX,HA,8MM L 014484 80 BV8W Imp, Bio-Vent, HA, 4.5mm, 8mm 017587 42 BV8W Imp, Bio-Vent, HA, 4.5mm, 8mm 0201661 39 BVT13 IMPLANT,B-V,INT HEX,1MM CLR,TPS,13MM L 0201113 36 BVT13W Imp, Bio-Vent, TPS, 4.5mm, 13mm 0200249 50 BVT16 Imp, Bio-Vent, TPS, 3.5mm, 16mm 0200250 50 BVT16W Imp, Bio-Vent, TPS, 4.5mm, 16mm 0201145 100
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Descripción del producto
    Biovent Implant Line
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • Empresa matriz del fabricante (2017)
  • 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