Device Recall METS

  • 모델명 / 제조번호(시리얼번호)
    A11290, A10107, A11828, A10610, A10765, A11439, A11922
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • 제품 설명
    Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stanmore Implants Worldwide Ltd., 210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Directly distributed to TX, further distributed to AL and MS
  • 제품 설명
    METS SMILES Total Knee Replacement
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • 제품 설명
    Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    B10191, B10443, B9920, B10561, B9921, B9922
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • 제품 설명
    Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    B10635, B11820, B12776, B10636, B10638, B9866
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • 제품 설명
    Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • 제품 설명
    DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer