Device Recall Versafitcup Total Hip SystemImpacting Ring

  • 모델명 / 제조번호(시리얼번호)
    Reference Number Lot Number Reference Number Lot Number 01.26.10.0133: 095920, 096050, 096050A; 01.26.10.0138: 095925, 096055, 096055A; 01.26.10.0134: 095921, 096051, 096051A; 01.26.10.0139: 095926, 096056, 096056A; 01.26.10.0135: 095922, 096052, 096052A; 01.26.10.0140: 095927, 096057, 096057A; 01.26.10.0136: 095923, 096053, 096053A; 01.26.10.0141: 095928, 096058, 096058A; 01.26.10.0137: 095924, 096054, 096054A; 01.26.10.0142: 095929, 096059, 096059A.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
  • 제품 설명
    Versafitcup Impacting Ring || Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). || Designed for cementless use in total hip arthroplasty.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medacta Usa Inc, 4725 Calle Quetzal Ste B, Camarillo CA 93012-8429
  • 제조사 모회사 (2017)
  • Source
    USFDA