Events

Device Recall Swissplus 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Dental Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    28217
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1144-04
  • 사례 시작날짜
    2004-01-13
  • 사례 출판 날짜
    2004-07-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31397
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Implant, Endosseous, Root-Form - Product Code DZE
  • 원인
    Sterility barrier compromised.

Device

Device Recall Swissplus
  • 모델명 / 제조번호(시리얼번호)
    SwissPlus Implant Line   Part # Description Lot Number Quantity HLRTX2 Tool, Removal, Ext Hex & Octagon Imp, SST 013348 170 HLRTX2 Tool, Removal, Ext Hex & Octagon Imp, SST 015085 324 OP2.3D DRILL,2.3MM,17MM 013188 100 OP2.3D DRILL,2.3MM,17MM 015887 199 OP2.8D DRILL,2.8MM,17MM 014649 224 OP3.5D DRILL,3.5MM,17MM 013935 150 OPA Abut, Straight, One-Piece, SP, Octagon Imp 015063 100 OPA Abut, Straight, One-Piece, SP, Octagon Imp 0201170 150 OPA Abut, Straight, One-Piece, SP, Octagon Imp 0202427 98 OPA Abut, Straight, One-Piece, SP, Octagon Imp 0203732 100 OPA/5 Abut/Transfer, SP, Octagon Imp, 5.2mm Flare 0202557 49 OPA2 Abut, Straight, Two-Piece, SP, Octagon Imp 015080 100 OPA2 Abut, Straight, Two-Piece, SP, Octagon Imp 0200208 149 OPA2 Abut, Straight, Two-Piece, SP, Octagon Imp 0202580 100 OPACT Abut, Tapered, SP, Octagon Imp, 1.6mm 0202065 49 OPB10 Impl, SwissPlus, Octagon, 4.1mm, 10mm 014390 301 OPB10 Impl, SwissPlus, Octagon, 4.1mm, 10mm 015321 262 OPB10 Impl, SwissPlus, Octagon, 4.1mm, 10mm 0200333 221 OPB10 Impl, SwissPlus, Octagon, 4.1mm, 10mm 0200536 200 OPB10 Impl, SwissPlus, Octagon, 4.1mm, 10mm 0201749 292 OPB10 Impl, SwissPlus, Octagon, 4.1mm, 10mm 0202891 172 OPB10 Impl, SwissPlus, Octagon, 4.1mm, 10mm 0203189 92 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 013547 146 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 013668 150 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 014231 144 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 015494 180 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 015500 298 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 016777 288 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 0201178 187 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 0201611 89 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 0202231 194 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 0203193 296 OPB12 Impl, SwissPlus, Octagon, 4.1mm, 12mm 0204618 162 OPB14 Impl, SwissPlus, Octagon, 4.1mm, 14mm 013669 93 OPB14 Impl, SwissPlus, Octagon, 4.1mm, 14mm 015342 200 OPB14 Impl, SwissPlus, Octagon, 4.1mm, 14mm 016719 200 OPB14 Impl, SwissPlus, Octagon, 4.1mm, 14mm 0201987 80 OPB8 Impl, SwissPlus, Octagon, 4.1mm, 8mm 013667 160 OPB8 Impl, SwissPlus, Octagon, 4.1mm, 8mm 017761 93 OPB8 Impl, SwissPlus, Octagon, 4.1mm, 8mm 0200982 155 OPB8 Impl, SwissPlus, Octagon, 4.1mm, 8mm 0202895 96 OPBA Abut, Ball, SwissPlus, Octagon Imp, 1.6mm 017022 75 OPBA Abut, Ball, SwissPlus, Octagon Imp, 1.6mm 0201537 78 OPBA Abut, Ball, SwissPlus, Octagon Imp, 1.6mm 0202428 50 OPC Coping, Castable Waxing, Plastic Transfer, SP, Oct 015087 100 OPCC Coping, Castable, Plastic, SP, Octagon Imp 0201171 50 OPCC Coping, Castable, Plastic, SP, Octagon Imp 0201521 99 OPCC Coping, Castable, Plastic, SP, Octagon Imp 0202336 66 OPGA Abut, Gold, SwissPlus, Octagon Imp 015108 154 OPGA Abut, Gold, SwissPlus, Octagon Imp 0201263 48 OPGA Abut, Gold, SwissPlus, Octagon Imp 0202233 50 OPH20 Abut, 20 deg, SwissPlus, Octagon Imp 0202710 52 OPR Replica, Imp, Octagon, SwissPlus 013572 581 OPR Replica, Imp, Octagon, SwissPlus 014492 421 OPWB10 Impl, SwissPlus, Octagon, 4.8mm, 10mm 013161 155 OPWB10 Impl, SwissPlus, Octagon, 4.8mm, 10mm 014408 242 OPWB10 Impl, SwissPlus, Octagon, 4.8mm, 10mm 016514 196 OPWB10 Impl, SwissPlus, Octagon, 4.8mm, 10mm 0201333 268 OPWB12 Impl, SwissPlus, Octagon, 4.8mm, 12mm 014238 199 OPWB12 Impl, SwissPlus, Octagon, 4.8mm, 12mm 015783 150 OPWB12 Impl, SwissPlus, Octagon, 4.8mm, 12mm 017245 97 OPWB12 Impl, SwissPlus, Octagon, 4.8mm, 12mm 0201112 138 OPWB12 Impl, SwissPlus, Octagon, 4.8mm, 12mm 0202581 150 OPWB14 Impl, SwissPlus, Octagon, 4.8mm, 14mm 016990 93 OPWB14 Impl, SwissPlus, Octagon, 4.8mm, 14mm 0201871 82 OPWB8 Impl, SwissPlus, Octagon, 4.8mm, 8mm 012894 119 OPWB8 Impl, SwissPlus, Octagon, 4.8mm, 8mm 0200209 121 OPWB8 Impl, SwissPlus, Octagon, 4.8mm, 8mm 0202665 68 OPWSCL Scr, Surgical Cover, SP, Octagon Imp, 3mm, 6mm Fla 013274 227 OT3.0-S Tool, Octagon, 3mm, 15mm, SST 012164 99 OT3.0-S Tool, Octagon, 3mm, 15mm, SST 012987 244 OT3.0-S Tool, Octagon, 3mm, 15mm, SST 015501 319 OTL3.0-S Tool, Octagon, 3mm, 26mm, SST 012740 100 OTL3.0-S Tool, Octagon, 3mm, 26mm, SST 014158 150 OTL3.0-S Tool, Octagon, 3mm, 26mm, SST 015962 70 OTL3.0-S Tool, Octagon, 3mm, 26mm, SST 016751 100 SP3D STEP DRILL,3.4/2.8MM,17MM 013132 102 SP3D STEP DRILL,3.4/2.8MM,17MM 014775 200 SP4D DRILL,4.4/3.8MM,17MM 013453 150 SP4D DRILL,4.4/3.8MM,17MM 015098 189 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 013441 165 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 013545 150 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 013670 104 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 014475 117 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 014497 283 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 014979 199 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 016761 109 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 016830 298 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 017283 258 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 0200924 298 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 0201500 296 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 0201619 287 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 0202804 206 SPB10 Impl, Tapered, SP, 3.7mm, 10mm, Octagon 0203168 463 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 013442 97 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 013546 198 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 014461 100 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 014498 182 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 014981 200 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 015810 177 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 017010 297 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 017125 300 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 0200412 296 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 0200638 299 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 0201009 266 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 0202340 228 SPB12 Impl, Tapered, SP, 3.7mm, 12mm, Octagon 0203086 279 SPB14 Impl, Tapered, SP, 3.7mm, 14mm, Octagon 012727 149 SPB14 Impl, Tapered, SP, 3.7mm, 14mm, Octagon 014149 95 SPB14 Impl, Tapered, SP, 3.7mm, 14mm, Octagon 014537 200 SPB14 Impl, Tapered, SP, 3.7mm, 14mm, Octagon 017031 199 SPB14 Impl, Tapered, SP, 3.7mm, 14mm, Octagon 0200373 195 SPB14 Impl, Tapered, SP, 3.7mm, 14mm, Octagon 0201702 201 SPB8 Impl, Tapered, SP, 3.7mm, 8mm, Octagon 014221 197 SPB8 Impl, Tapered, SP, 3.7mm, 8mm, Octagon 017674 300 SPMB10 Impl, Tapered, SP, 3.7mm, 10mm, Hexagon 012893 150 SPMB10 Impl, Tapered, SP, 3.7mm, 10mm, Hexagon 014647 196 SPMB10 Impl, Tapered, SP, 3.7mm, 10mm, Hexagon 017008 142 SPMB10 Impl, Tapered, SP, 3.7mm, 10mm, Hexagon 0201148 198 SPMB10 Impl, Tapered, SP, 3.7mm, 10mm, Hexagon 0201498 184 SPMB10 Impl, Tapered, SP, 3.7mm, 10mm, Hexagon 0202620 264 SPMB12 Impl, Tapered, SP, 3.7mm, 12mm, Hexagon 014736 92 SPMB12 Impl, Tapered, SP, 3.7mm, 12mm, Hexagon 015502 197 SPMB12 Impl, Tapered, SP, 3.7mm, 12mm, Hexagon 017367 147 SPMB12 Impl, Tapered, SP, 3.7mm, 12mm, Hexagon 0201010 200 SPMB12 Impl, Tapered, SP, 3.7mm, 12mm, Hexagon 0201549 153 SPMB12 Impl, Tapered, SP, 3.7mm, 12mm, Hexagon 0202558 148 SPMB14 Impl, Tapered, SP, 3.7mm, 14mm, Hexagon 012853 150 SPMB14 Impl, Tapered, SP, 3.7mm, 14mm, Hexagon 016027 134 SPMB14 Impl, Tapered, SP, 3.7mm, 14mm, Hexagon 017695 150 SPMB14 Impl, Tapered, SP, 3.7mm, 14mm, Hexagon 0201361 149 SPMB14 Impl, Tapered, SP, 3.7mm, 14mm, Hexagon 0202666 65 SPMB8 Impl, Tapered, SP, 3.7mm, 8mm, Hexagon 012990 96 SPMB8 Impl, Tapered, SP, 3.7mm, 8mm, Hexagon 016968 100 SPSCL Scr, Surgical Cover, SP, Hexagon Impl, 3mm, 4.6mm 013192 77 SPSCL Scr, Surgical Cover, SP, Hexagon Impl, 3mm, 4.6mm 013192 104 SPSCS Scr, Surgical Cover, SP, Hexagon Impl, 1mm, 4.6mm 013193 150 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 012845 147 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 013571 90 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 013893 119 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 014474 127 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 014940 293 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 015787 200 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 016908 100 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 0200272 108 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 0200832 289 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 0201528 96 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 0201995 193 SPWB10 Impl, Tapered, SP, 4.8mm, 10mm, Octagon 0203190 273 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 012904 137 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 013517 147 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 014237 91 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 014415 90 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 014785 110 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 016357 109 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 016524 140 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 016591 236 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 0200862 244 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 0201494 197 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 0201660 170 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 0203077 175 SPWB12 Impl, Tapered, SP, 4.8mm, 12mm, Octagon 0203191 81 SPWB14 Impl, Tapered, SP, 4.8mm, 14mm, Octagon 014240 138 SPWB14 Impl, Tapered, SP, 4.8mm, 14mm, Octagon 016848 198 SPWB14 Impl, Tapered, SP, 4.8mm, 14mm, Octagon 0200364 101 SPWB14 Impl, Tapered, SP, 4.8mm, 14mm, Octagon 0201703 147 SPWB8 Impl, Tapered, SP, 4.8mm, 8mm, Octagon 012858 116 SPWB8 Impl, Tapered, SP, 4.8mm, 8mm, Octagon 015335 92 SPWB8 Impl, Tapered, SP, 4.8mm, 8mm, Octagon 015895 101 SPWB8 Impl, Tapered, SP, 4.8mm, 8mm, Octagon 017032 94 SPWB8 Impl, Tapered, SP, 4.8mm, 8mm, Octagon 017126 82 SPWB8 Impl, Tapered, SP, 4.8mm, 8mm, Octagon 0202102 125
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 제품 설명
    Swissplus Implant Line
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

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