Events

Device Recall Taperlock 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-1145-04
  • 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=31398
  • 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 Taperlock
  • 모델명 / 제조번호(시리얼번호)
    Taperlock Implant Line    Part # Description Lot Number Quantity DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 013389 80 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 014246 65 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 014838 164 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 016187 250 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 016747 86 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 0202572 99 IAX Analog, Imp, Ext Hex 014247 400 IAX Analog, Imp, Ext Hex 014248 256 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 014491 50 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 015558 70 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 017544 52 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 0202426 50 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 0202686 70 ITX/6 Xfr, Indirect, Ext Hex Imp, 6.5mm Flare 014476 50 THCX3/4 Healing Collar, Ti, Ext Hex Imp, 3mm, 4.5mm Flare 013086 110 THCX3/4 Healing Collar, Ti, Ext Hex Imp, 3mm, 4.5mm Flare 014251 300 THCX3/4 Healing Collar, Ti, Ext Hex Imp, 3mm, 4.5mm Flare 015122 184 THCX3/5 Healing Collar, Ti, Ext Hex Imp, 3mm, 5.5mm Flare 013276 98 THCX3/5 Healing Collar, Ti, Ext Hex Imp, 3mm, 5.5mm Flare 015118 149 THCX5/4 Healing Collar, Ti, Ext Hex Imp, 5mm, 4.5mm Flare 015221 257 THCX5/5 Healing Collar, Ti, Ext Hex Imp, 5mm, 5.5mm Flare 012928 100 THCX5/5 Healing Collar, Ti, Ext Hex Imp, 5mm, 5.5mm Flare 014536 85 TLB10 Impl, Scr, Taper-Lock, SBM, 4mm, 10mm 015538 169 TLB10 Impl, Scr, Taper-Lock, SBM, 4mm, 10mm 0201547 225 TLB10 Impl, Scr, Taper-Lock, SBM, 4mm, 10mm 0202622 96 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 012905 297 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 013744 113 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 015539 310 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 0202562 90 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 0202728 195 TLB16 Impl, Scr, Taper-Lock, SBM, 4mm, 16mm 0201548 99 TLB16 Impl, Scr, Taper-Lock, SBM, 4mm, 16mm 0202949 96 TLB8 Impl, Scr, Taper-Lock, SBM, 4mm, 8mm 013743 81 TLB8 Impl, Scr, Taper-Lock, SBM, 4mm, 8mm 016755 136 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 014722 101 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 015540 95 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 0200510 125 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 0201616 95 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 0203101 396 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 013090 166 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 013203 79 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 013837 344 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 014097 120 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 015422 88 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 015808 84 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 016808 117 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 017259 100 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 017259 361 TLH16 Impl, Scr, Taper-Lock, HA, 4mm, 16mm 016756 97 TLH8 Impl, Scr, Taper-Lock, HA, 4mm, 8mm 014273 101 TLH8 Impl, Scr, Taper-Lock, HA, 4mm, 8mm 0203102 100 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 013170 99 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 014280 148 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 0200704 100 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 0201018 89 TLMB13 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 13mm 012367 209 TLMB13 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 13mm 015543 240 TLMB13 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 13mm 0202873 147 TLMB8 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 8mm 0201502 50 TLMH10 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 10mm 015541 122 TLMH13 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 13mm 016376 85 TLMH13 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 13mm 017309 98 TLMH13 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 13mm 0200104 118 TLMH16 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 16mm 014978 94 TLMH16 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 16mm 0202432 99 TLMH8 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 8mm 0200887 38 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 014507 200 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 015089 349 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 016688 400 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 016964 296 TLSD Drill, Twist Tri-Spade, Taper-Lock Scr, 3.5mm, 17m 012057 174 TLSD Drill, Twist Tri-Spade, Taper-Lock Scr, 3.5mm, 17m 014770 150 TLSDS DRILL,3.5MM,11MM 011972 67 TLSDS DRILL,3.5MM,11MM 013356 190 TLSMD16 Drill, Twist Tri-Spade, T-L, C''sink, 2.8mm, 16mm 011973 53 TLSMD8 Drill, Twist Tri-Spade, T-L, C''sink, 2.8mm, 8mm 012052 150 TLSMD8 Drill, Twist Tri-Spade, T-L, C''sink, 2.8mm, 8mm 015791 51 TLWB13 Impl, Scr, Taper-Lock, SBM, 4.7mm, 4mm, 13mm 015544 147 TLWB16 Impl, Scr, Taper-Lock, SBM, 4.7mm, 4mm, 16mm 0202816 69 TLWB8 Impl, Scr, Taper-Lock, SBM, 4.7mm, 4mm, 8mm 012927 107 TLWH10 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 10mm 013302 245 TLWH10 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 10mm 0200120 103 TLWH10 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 10mm 0203192 41 TLWH13 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 13mm 015545 89 TLWH13 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 13mm 016918 95 TLWH16 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 16mm 016789 50 TLWH8 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 8mm 014535 40 TLWH8 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 8mm 017136 50
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 제품 설명
    Taperlock 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